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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Amneal Submits US BLA for Omalizumab Biosimilar

Sep 26, 2025

On 26 September 2025, Amneal Pharmaceuticals announced that it submitted a Biologics License Application (BLA) to the US FDA for ADL-018 (omalizumab), biosimilar to Novartis’ Xolair®.

ADL-018 was developed by Kashiv Biosciences, with Amneal holding exclusive US commercialisation rights for the product under a July 2024 licensing agreement.

Kashiv has also entered into agreements for the commercialisation of ADL-018 in other regions, including with CRISTÁLIA for LATAM markets (August 2025), MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023). A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Kashiv commenced Phase III trials of ADL-018 in October 2023 (patient enrolment completed in July 2024) in patients with chronic idiopathic/spontaneous urticaria following completion of Phase I trials in June 2023.

On 19 September 2025, Celltrion announced that it will begin the European launch of its biosimilar omalizumab, Omlyclo®, in Norway. Omalizumab biosimilars are also being developed by Aurobindo, Teva and Glenmark.

German Court Grants Cross-Border PI Preventing Launch of Formycon’s Biosimilar Aflibercept

Sep 25, 2025

On 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept). According to the Juve Patent report, the PI covers 22 European countries, including Germany and is based on a finding of infringement by equivalence of Regeneron’s formulation patent, EP 2 364 691. The judgment is not yet available in English.

FYB203 received European marketing approval in January 2025 as Baiama® and Ahzantive® and UK approval in February 2025. FYB203 was developed by Formycon, and Klinge holds the exclusive commercialisation rights. In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 (as Ahzantive®) in Europe (excluding Italy) and Israel. On 17 September 2025, Formycon announced that Klinge had entered a semi-exclusive licence agreement with Horus Pharma, for the commercialisation of FYB203 (under the brand name Baiama®) in selected European countries.

The dispute between Regeneron/Bayer and Formycon in relation to FYB203 is not limited to Germany, with legal proceedings in the US, UK, Italy, Belgium, the Netherlands, and France. In the US, FYB203 is subject to a preliminary injunction granted in June 2024, resulting from a patent infringement proceeding brought by Regeneron in November 2023, which was upheld on appeal in January 2025. In the UK, a hearing in the infringement action brought by Regeneron and Bayer against Formycon and Klinge’s FYB203 took place in the High Court (Patents Court) in June 2025. The UK Court decision is pending.

Regeneron/Bayer Appeal Australian Court’s Refusal to Grant PI and Prevent Launch of Sandoz’s Biosimilar Aflibercept

Sep 25, 2025

Regeneron and Bayer have moved swiftly to appeal Justice Rofe’s decision denying Regeneron and Bayer’s application for PI on MOT patent AU2012205599 to restrain Sandoz from launching its biosimilar aflibercept (Afqlir® and Enzeevu®) in Australia. Our report on her Honour’s decision can be found here.

On 17 September 2025, Regeneron filed an application for leave to appeal Justice Rofe’s decision. There is no automatic right to appeal from an interlocutory decision of the Federal Court of Australia and Regeneron/Bayer must obtain leave before the Full Court will hear the appeal. Often the leave application and, if leave is granted, the substantive appeal, are heard at the same time.

The Federal Court has listed the matter for hearing of both the leave application and the appeal on 29 October 2025 before Justices Beach, Burley and Moshinsky.

The case is of considerable interest, particularly given the number of biosimilar competitors, including Samsung Bioepis and Celltrion, that are lining up to enter the Australian aflibercept market. Actor Pharmaceuticals, which does not yet have an aflibercept biosimilar approved in Australia, also filed revocation proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter currently scheduled for 8 October 2025.

About Pearce IP

Pearce IP is a specialist firm offering intellectual property specialist lawyers and attorneys with a focus on the life sciences industries. Pearce IP and its leaders are ranked in every notable legal directory for legal, patent and trade mark excellence, including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, 5 Star IP Lawyers, among others.

In 2025, Pearce IP was recognised by Australasian Lawyer and New Zealand Lawyer’s 5 Star Employer of Choice, and is the “Standout Winner” for inclusion and culture for firms with less than 100 employees. Pearce IP was awarded “IP Team of the Year” by Lawyers Weekly at the 2021 Australian Law Awards. Pearce IP is recognised by Managing IP as the only leading ANZ IP firm with a female founder, and is certified by WEConnect International as women owned.

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information.

Throughout her career, Helen has maintained a strong focus on high-value patent mandates involving complex technologies. In these mandates, Helen has been able to draw upon her technical training in biochemistry and molecular biology, as well as her ability to up-skill swiftly in relation to diverse technologies. Helen’s patent work has encompassed the technical fields of inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology) and physics.

Helen is a member of the Intellectual Property Committee of the Law Council of Australia, as well as a member of the Intellectual Property Society of Australia and New Zealand.

Intas Required to Revise Biosimilar Pembrolizumab Trial Protocol in India

Sep 24, 2025

On 24 September 2025, Medical Dialogues reported that India’s Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) has instructed Intas Pharmaceuticals to submit a revised protocol for its proposed biosimilar pembrolizumab Phase I/III clinical trial.

Intas’ proposed clinical trial is intended to be a multicentre study comparing the efficacy, safety, pharmacokinetics and immunogenicity of INTP58 with MSD’s Keytruda® (pembrolizumab), both administered with chemotherapy, in first line treatment of locally advanced or metastatic squamous or non-squamous non-small cell lung cancer. The SEC raised a number of issues in relation to the trial protocol, including that the study duration should be increased, and the dose of chemotherapy (paclitaxel) should be reduced.

There are a number of pembrolizumab biosimilars already in clinical trials, including those of Samsung Bioepis, Amgen, mAbxience, Sandoz, Formycon, Celltrion, Shanghai Henlius, Bio-Thera and BioNTech. Alvotech and Dr Reddy’s entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®. Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay in August 2025, under the name Pembrolizumab Bioéticos.

New Zealand’s Pharmac Proposing to Fund Multiple Roche Biologics

Sep 24, 2025

New Zealand’s drug funding agency, Pharmac, has opened for public consultation a provisional agreement with Roche to fund a package of Roche drugs, including subcutaneous formulations of biologics previously only funded as IV treatments. The agreement includes the following biologics:

Avastin® (bevacizumab) for ocular conditions only. This represents a rare example of Pharmac funding two suppliers’ brands of the same biologic. Celltrion’s bevacizumab biosimilar, Vegzelma®, was awarded Principal Supply Status for all reference indications by Pharmac in February 2025. However, the agreement with Celltrion specifically allowed other brands to be funded for ocular conditions only.
Ocrevus® SC (ocrelizumab), alongside IV Ocrevus®. Most patients are expected to switch to Ocrevus® SC. No ocrelizumab biosimilars have been submitted for approval in New Zealand to date.
Phesgo® (pertuzumab and trastuzumab) for subcutaneous treatment of HER2-positive metastatic breast cancer. Roche’s Perjeta® (pertuzumab) and Celltrion’s Herzuma® (biosimilar trastuzumab) are already funded as separate IV infusions for people with HER2-positive metastatic breast cancer. It is expected that most patients receiving these in combination will now receive Phesgo® as it can be administered faster than the IV infusions, providing the same treatment benefit with less time spent receiving treatment.
Vabysmo® (faricimab) for diabetic macular oedema and wet age-related macular degeneration. Funding criteria will be the same as updated criteria for aflibercept (Regeneron’s Eylea®). Criteria for funding ranibizumab are also being updated.
Gazyva® (obinutuzumab) and MabThera® (rituximab) will have funding criteria updated. No MabThera® biosimilar is currently funded for rheumatoid arthritis to date due to Roche patent protection subsisting in New Zealand for that indication. Sandoz’s biosimilar rituximab, Riximyo®, is funded for all other (off-patent) indications.

Submissions on the provisional agreement may be made until 5.00pm 8 October 2025 (NZ time).

Celltrion’s Application for Biosimilar Aflibercept Indication Extension Under Review in Australia

Sep 24, 2025

On 24 September 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for the months of July, August and September. Among the additions is Celltrion’s July 2025 application for an indication extension to Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept 2mg), for all reference indications.

Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV). It was followed by Sandoz’s Afqlir® and Enzeevu® on 27 May 2025, and Samsung Bioepis’ Opuviz® on 18 September 2025, which were each approved for all reference indications. Sandoz’s products were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme with listing anticipated on 1 December 2025.

Aflibercept is currently the subject of patent infringement and revocation proceedings in Australia against Sandoz, with Actor separately challenging Regeneron/Bayer aflibercept patents. On 8 September 2025, the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer an interlocutory injunction against Sandoz to prevent the launch of Sandoz’s Afqlir® in light of Regeneron 2032 expiring MOT patent AU2012205599. Regeneron/Bayer filed an application for leave to appeal that decision on 17 September 2025, with the Full Court to hear the leave application on 29 October 2025. Regeneron/Bayer are also separately seeking preliminary discovery from Sandoz in relation to a second Regeneron aflibercept 2040 expiring process patent AU2020397865, with a hearing scheduled in that matter on 6 November 2025.

Actor Pharmaceuticals, which does not yet have an aflibercept biosimilar approved in Australia filed revocation proceedings in the Australian Federal Court on 5 August 2025 seeking to invalidate Regeneron’s AU2012205599. A first case management hearing in that matter is currently scheduled for 8 October 2025.

Pearce IP BioBlast® for the week ending 19 September 2025

Sep 23, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 19 September 2025 are set out below:

Aflibercept

21 September 2025 | IN | CA | Biocon’s Biosimilar Aflibercept Recommended in India; Publicly Funded in Canada

18 September 2025 | AU | Samsung Bioepis’ Aflibercept Biosimilar Third to be Approved in Australia

On 18 September 2025, Samsung Bioepis’ Opuviz®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), was approved by Australia’s Therapeutic Goods Administration (TGA) in 2 presentations… Read more here.

17 September 2025 | AU | Regeneron/Bayer Appeal Australian Court’s Refusal to Grant PI and Prevent Launch of Sandoz’s Biosimilar Aflibercept

On 17 September 2025, Regeneron filed an application for leave to appeal the decision of Justice Rofe of the Federal Court of Australia refusing to award Regeneron/Bayer a preliminary injunction against Sandoz… Read more here.

17 September 2025 | US | Alvotech Files US PGR Challenging Regeneron’s Method of Treatment Patent for High Dose Aflibercept

On 17 September 2025, Alvotech filed a petition for post grant review of Regeneron’s patent… Read more here.

17 September 2025 | EU | Alteogen’s Biosimilar Aflibercept EU Approved

On 17 September 2025, Alteogen announced that the European Commission has approved Eyluxvi® (ALT-L9), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)… Read more here.

17 September 2025 | EU | Formycon/Klinge’s Biosimilar Aflibercept to be Commercialised by Horus Pharma in EU

On 17 September 2025, Formycon announced that Klinge Biopharma, the exclusive holder of the global commercialisation rights for Formycon’s FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)… Read more here.

Denosumab

19 September 2025 | EU | European Commission Approves Shanghai Henlius/Organon’s Denosumab Biosimilars

On 19 September 2025, Shanghai Henlius and Organon announced that the European Commission has approved Bildyos® and Bilprevda® (HLX14)… Read more here.

19 September 2025 | CuraTeQ Announces Positive Ph 3 Results for Biosimilar Denosumab

On 19 September 2025, Aurobindo Pharma subsidiary, CuraTeQ Biologics, announced positive results from its Phase 3 trial of BP16… Read more here.

18 September 2025 | CA | Celltrion’s Denosumab Biosimilars Second to be Approved in Canada

On 18 September 2025, Celltrion announced that Health Canada has granted approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s… Read more here.

17 September 2025 | US | FDA Approves Biocon’s Denosumab Biosimilars Bosaya™ and Aukelso™

On 17 September 2025, Biocon Biologics announced that it received FDA approval for denosumab products Bosaya™ and Aukelso™, biosimilars to Amgen’s… Read more here.

Golimumab, Denosumab, Ustekinumab

19 September 2025 | EU | Positive CHMP Opinions for 9 Biosimilars – Good News for Alvotech, Advanz, STADA, Dr Reddy’s, Teva, Intas & Bio-Thera

On 19 September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its September meeting… Read more here.

Golimumab, Denosumab, Aflibercept

19 September 2025 | JP | Alvotech/Fuji Pharma’s JP Golimumab Biosimilar First Approved Worldwide; Aflibercept & Denosumab Biosimilars Also JP Approved

On 19 September 2025, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare for 3 biosimilars … Read more here.

Omalizumab

19 September 2025 | NO | Celltrion Launches Biosimilar Omalizumab in Norway; Presents Ph 3 Results from Switching Study

On 19 September 2025, Celltrion announced that it will begin the European launch of Omlyclo®, biosimilar to Genentech’s Xolair® (omalizumab), in Norway… Read more here.

Pembrolizumab

19 September 2025 | US | EU | MSD’s Subcutaneous Keytruda® (Pembrolizumab) Approved in US & Recommended in EU

On 19 September 2025, MSD announced that Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph; MK-3475A) has been approved by the FDA for subcutaneous use in adults… Read more here.

Secukinumab

15 September 2025 | MENA | Bio-Thera & Jamjoom Pharma Partner on Secukinumab Biosimilar in MENA

On 15 September 2025, Bio-Thera and Saudi Arabia-headquartered Jamjoom Pharmaceuticals Factory Company announced they have entered a strategic commercialisation… Read more here.

Tocilizumab

22 September 2025 | JP | Celltrion’s Biosimilar Tocilizumab First to be Approved in Japan

On 22 September 2025, Celltrion announced that Japan’s Ministry of Health, Labor and Welfare has approved Avtozma®/CT-P47, biosimilar to Roche’s Actemra® … Read more here.

Ustekinumab

16 September 2025 | JP | Mitsubishi Tanabe’s Co-Promotion of Janssen’s Stelara® to End on 31 December 2025 in Japan

On 16 September 2025, First Word Pharma reported that Mitsubishi Tanabe Pharma Corporation’s (MTPC) contract with Janssen for co-promotion activities for Janssen’s Stelara®… Read more here.

10 September 2025 | NL | Dutch Court Validates Janssen’s Ustekinumab Patent for Treating UC

On 10 September 2025, the District Court of The Hague delivered judgment in Samsung Bioepis’ revocation action against Janssen’s EP 3 883 606 (the Janssen Patent)… Read more here.

About Pearce IP

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Nathan Kan

Lawyer

Nathan is a lawyer specialising in life sciences, providing legal advice and litigation support across intellectual property and commercial disputes. He is passionate about the intersection of law and science, and during his time with the Science and Technology Law Association at the University of Melbourne, he helped lead events, workshops and publications across STEM fields including life sciences, AI and digital transformation.

Subcutaneous Nivolumab Recommended for Reimbursement in Canada for Solid Tumour Indications

Sep 23, 2025

On 23 September 2025, Bristol Myers Squibb announced that the Institut national d’excellence en santé et en services sociaux (INESSS) has issued a positive recommendation for the reimbursement of Opdivo® SC (nivolumab for subcutaneous injection) in Quebec across Health Canada-authorised solid tumour indications where Opdivo® (nivolumab) for intravenous infusion is reimbursed.

Opdivo® SC was approved for solid tumour indications in Canada and the EU in May 2025, following similar approvals in the US (December 2024) and UK (April 2025).

At least Amgen, Sandoz and Xbrane/Intas have nivolumab biosimilars under development, and Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.

First Canakinumab Biosimilar Approved in Russia

Sep 23, 2025

On 23 September 2025, GxP News reported that Russian company, Generium, has obtained registration of the first Russian biosimilar to Novartis’ Ilaris® (canakinumab). The biosimilar, Limiris™, has been approved as a lyophilised powder for subcutaneous injection and is indicated for the treatment of Still’s disease, systemic juvenile idiopathic arthritis, autoinflammatory diseases, and gouty arthritis.

Generium offers a number of biosimilar products in Russia including Elizaria®, biosimilar to Alexion’s Soliris® (eculizumab) (approved April 2019) and Genolar®, biosimilar to Genentech’s Xolair® (omalizumab) (approved February 2022).

There have not been any reports of canakinumab biosimilars approved elsewhere. However, in May 2025, Alvotech and Advanz expanded their partnership to include the development and commercialisation of a canakinumab biosimilar in Europe.

Sam Chun Dang’s Biosimilar Aflibercept Approved in Japan and Korea

Sep 23, 2025

On 23 September 2025, Korea Biomedical Review reported that Sam Chun Dang’s SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved in both Japan and Korea in vial and pre-filled syringe (PFS) forms.

The latest approvals follow SCD411’s Canadian approval on 26 June 2025 and European approval in August 2025, also in vial and PFS forms. At the time of the European approval, SCD considered it may be the first to launch a PFS aflibercept biosimilar in Europe, after being the first to do so in Canada. SCD reportedly licensed SCD411 to Apotex for the Canadian market (August 2023), to an unnamed distributor for Austria, Germany, Italy, Spain and Switzerland (November 2023), and to a further unnamed distributor for the UK, Belgium, Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland (March 2024).

In July 2025, the Seoul Central District Court refused Regeneron/Bayer’s request for an order that SCD submit various documents and information in connection with a lawsuit alleging that SCD’s licence agreement with an unnamed overseas company to supply SCD411 constituted infringement of Regeneron’s Korean Patent 659477.

Alvotech/Fuji Pharma received Japanese approval for biosimilar aflibercept (AVT06) earlier this month (September 2025). In Korea Samsung Bioepis’ Afilivu® (SB15) (February 2024) andCelltrion’s Eydenzelt® (CT-P42) (May 2024) have been approved.

Celltrion’s Biosimilar Tocilizumab First to be Approved in Japan

Sep 22, 2025

On 22 September 2025, Celltrion announced that Japan’s Ministry of Health, Labor and Welfare has approved Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Castleman disease (CD), and cytokine release syndrome (CRS).

This marks the first tocilizumab biosimilar approved in Japan, with Celltrion planning to launch “quickly” to secure “first mover advantage”.

In May 2025, Avtozma® became the first approved tocilizumab biosimilar in Australia. In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

Avtozma® was also the third tocilizumab biosimilar approved in the US in January 2025, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

Enzene’s Pertuzumab Biosimilar Launched in India

Sep 22, 2025

On 22 September 2025, Enzene Biosciences announced the Indian launch of its biosimilar to Roche’s Perjeta® (pertuzumab). According to Enzene, the biosimilar is being marketed in India by “multiple leading pharmaceutical companies”. This includes Enzene’s parent company, Alkem Laboratories, which is marketing the biosimilar under the name Pertuza®, and Hetero Healthcare, which has announced the launch of the Enzene biosimilar under the name Perzea®.

Other pertuzumab biosimilars approved in India include Intas’ biosimilar (approved December 2024) and Zydus’ Sigrima™ (approved June 2024). Sigrima™ is the subject of legal action in India by Roche, which is alleging infringement of patents IN268632 and IN464646.

Roche has recently indicated that biosimilar competition to Perjeta® is a bigger concern than it previously anticipated. As well as the Indian proceedings against Zydus, Roche has also sued Shanghai Henlius and Organon in the US, alleging that their pertuzumab biosimilar, HLX11, infringes multiple US patents.

Amgen’s High-Concentration Adalimumab Biosimilar AU Approved

Sep 22, 2025

On 22 September 2025, Australia’s Therapeutic Goods Administration approved Amgen’s high-concentration Amgevita® (100mg/ml), biosimilar to AbbVie’s Humira® (adalimumab), in the following presentations:

20mg/0.2mL (484565) and 40mg/0.4mL (484554) injection solution syringe; and
40mg/0.4mL (484553) and 80mg/0.8mL (486685) injection solution syringe with a pen injector.

There are a number of other high-concentration adalimumab biosimilars approved in Australia, including Celltrion’s Yuflyma® (March 2022), Alvotech/Cipla’s Ciptunex®/Adalicip® (September 2022), Samsung Bioepis’ Hadlima® (February 2023) and Sandoz’s Hyrimoz® (May 2024).

In March 2025, Sandoz’s high-concentration Hyrimoz® (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira® indications, which followed PBS-listing of the 40 mg/0.4 mL injection, 2 x 0.4 mL pen presentation in January 2025.

Biocon’s Biosimilar Aflibercept Recommended in India; Publicly Funded in Canada

Sep 21, 2025

On 21 September 2025, Medical Dialogues reported that Biocon has received recommendations from India’s Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to import and market its biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) in India for multiple ophthalmic indications (in 40mg/ml vial form for injection). Biocon is required to submit a Phase IV (post-marketing) clinical trial protocol to the CDSCO within 3 months of the grant of marketing authorisation.

Biocon also announced on 18 September 2025 that Yesafili® (aflibercept), in vial and prefilled syringe presentations, is now publicly funded on the Ontario Drug Benefit Formulary/Comparative Drug Index for the advanced treatment of patients with retinal diseases.

Yesafili® was reported to be the first aflibercept biosimilar approved in Canada in June 2025 and was launched in July 2025 under a March 2024 settlement between Biocon and Regeneron/Bayer.

Biocon’s Yesafili® was approved in Europe in September 2023 but is not yet on the market. In April 2025, Biocon and Regeneron settled US BPCIA litigation regarding aflibercept, paving the way for a US launch of Yesafili® in the second half of 2026, or earlier under certain undisclosed circumstances.

MSD’s Subcutaneous Keytruda® (Pembrolizumab) Approved in US & Recommended in EU

Sep 19, 2025

On 19 September 2025, MSD announced that Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph; MK-3475A) has been approved by the FDA for subcutaneous use in adults across 38 indications, covering most solid tumour indications for Keytruda® (pembrolizumab). MSD is planning a late September 2025 US launch for Keytruda Qlex™.

According to Business Korea, if Keytruda Qlex™ successfully penetrates the market, Alteogen, the developer of hyaluronidase technology used with the subcutaneous formulation, is expected to generate annual royalty income exceeding 1 trillion won.

The FDA had accepted MSD’s BLA for SC pembrolizumab in March 2025, with a target action date of 23 September 2025.

The good news for MSD comes a day after the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended a change to the marketing authorisation for MSD’s Keytruda®, adopting a new pharmaceutical form, solution for injection, associated with two new strengths (790 mg and 305 mg), together with subcutaneous use as a new route of administration.

MSD was sued by Halozyme in the US on 24 April 2025 in relation to SC pembrolizumab, with Halozyme alleging that it infringes 15 patents owned by Halozyme in relation to MDASE subcutaneous delivery platform. The lawsuit followed reports in March 2025 that Halozyme had offered MSD an opportunity to licence its MDASE patents. At the time, a spokesperson from MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that MSD “strongly believe” that any Halozyme patents that attempt to cover the enzyme variant are invalid.

MSD has filed 14 petitions for post-grant review with the US Patent Trial and Appeal Board challenging the validity of US patents owned by Halozyme, a number of which are asserted in the litigation. The petitions were filed between November 2024 and June 2025. Petitions in relation to 5 patents have been instituted (US 11952600 (2 June 2025), US 12018298 (11 June 2025), US 12152262 (16 June 2025), US 12123035 (11 July 2025), US 12110520 (8 September 2025)), while others are pending.

Celltrion Launches Biosimilar Omalizumab in Norway; Presents Ph 3 Results from Switching Study

Sep 19, 2025

On 19 September 2025, Celltrion announced that it will begin the European launch of Omlyclo®, biosimilar to Genentech’s Xolair® (omalizumab), in Norway. The announcement comes only 9 days after Celltrion said that it was set to “launch in Europe as a ‘first mover’ within the year”.

On the same date, Celltrion also announced results from its global Phase 3 clinical trial of Omlyclo®, involving 619 patients with chronic spontaneous urticaria. Starting from week 12, patients who received Omlyclo® were continued on the same treatment and patients who initially received 300mg of the reference product were re-randomised in a 1:1 ratio to either switch to Omlyclo® or to continue receiving the reference product. The results demonstrated comparable efficacy and safety to the reference product.

Omlyclo® is approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025). The Celltrion product has been the subject of patent infringement actions in at least the UK and Europe.

Aurobindo, Teva, Glenmark and Kashiv reportedly also have omalizumab biosimilars under development.

On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market. Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023). A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Alvotech/Fuji Pharma’s JP Golimumab Biosimilar First Approved Worldwide; Aflibercept & Denosumab Biosimilars Also JP Approved

Sep 19, 2025

On 19 September 2025, Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received approval from the Japanese Ministry of Health, Labour and Welfare for 3 biosimilars:

Golimumab: AVT05 (GOLIMUMAB BS 50 mg PFS for subcutaneous injection), biosimilar to Janssen’s Simponi®;
Denosumab: AVT03 (DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection), biosimilar to Daiichi Sankyo’s Ranmark®, which is marketed in other countries as Amgen’s Xgeva®; and
Aflibercept AVT06 (AFLIBERCEPT BS 40 mg/mL solution in PFS for IV injection and 40 mg/mL vial kit for IV injection), biosimilar to Regeneron/Bayer’s Eylea®.

Alvotech considers that the Japanese approval of AVT05 is the first golimumab biosimilar approval in any major market. Alvotech/Fuji’s AVT04, biosimilar to J&J’s Stelara®, was the first ustekinumab biosimilar approved in Japan in September 2023.

Alvotech and Fuji Pharma first announced they had entered into a commercialisation agreement for Japan in 2018, with the agreement expanded in February 2022 and January 2023. The agreement covers the four approved biosimilars, plus two unnamed biosimilar candidates currently under development.

In January 2025, Celltrion announced plans to launch its denosumab (CT-P41) and aflibercept (CT-P42) biosimilars in Japan during 2025, together with ustekinumab (CT-P43), omalizumab (CT-P39) and tocilizumab (CT-P47) biosimilars.

Positive CHMP Opinions for 9 Biosimilars – Good News for Alvotech, Advanz, STADA, Dr Reddy’s, Teva, Intas & Bio-Thera

Sep 19, 2025

On 19 September 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcomes of its September meeting, adopting positive opinions for the following nine biosimilars:

Golimumab: Alvotech/Advanz Pharma’s Gobivaz® (AVT05), biosimilar to J&J’s Simponi® (golimumab). In November 2024, Alvotech/Advanz Pharma’s European MAA for AVT05 was the first golimumab biosimilar MAA to be accepted anywhere in the world;
Denosumab: STADA/Alvotech’s Kefdensis® and Zvogra® (AVT03, MAA accepted October 2024), Dr Reddy’s Acvybra® and Xbonzy®, and Teva’s Ponlimsi™ and Degevma™ (TVB-009P, MAA accepted October 2024), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) and Intas’ Denosumab Intas, biosimilar to Amgen’s Prolia® (denosumab);
Ustekinumab: Bio-Thera/STADA’s Usgena™ (BAT2506), biosimilar to J&J/Janssen’s Stelara® (ustekinumab). Bio-Thera and STADA entered an exclusive commercialisation agreement in relation to BAT2506 in May 2024 under which Bio-Thera has responsibility for development and manufacturing the biosimilar while STADA has exclusive commercialisation rights in the EU, UK, Switzerland and certain other countries.

There are currently 8 sponsors with denosumab biosimilars approved in Europe although none have launched to date: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025) and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025). Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025.

There are no golimumab biosimilars approved in the EU, so Alvotech is likely to have the first EU approved biosimilar golimumab. Following acceptance of Alvotech/Advanz’s MAA for AVT05 in November 2024, Bio-Thera/STADA’s MAA for BAT2506 was accepted by the EMA in February 2025.

There are a number of ustekinumab biosimilars now marketed in EU, with STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® launched in July 2024 and Celltrion’s Steqeyma® launched in November 2024. Approved ustekinumab biosimilars in Europe include Amgen’s Wezenla™ (June 2024), Samsung Bioepis’ Eksunbi™ (September 2024), Fresenius’ Otulfi®/FYB202 and Formycon’s Fymskina® (September 2024), Accord’s Imuldosa® and Absimky® (December 2024) and Biocon’s Yesintek® (February 2025).

CuraTeQ Announces Positive Ph 3 Results for Biosimilar Denosumab

Sep 19, 2025

On 19 September 2025, Aurobindo Pharma subsidiary, CuraTeQ Biologics, announced positive results from its Phase 3 trial of BP16, biosimilar to Amgen’s Prolia® (denosumab).

The study, which was conducted across 40 sites in five European countries on 446 postmenopausal women, evaluated the biosimilar’s efficacy in improving bone mineral density (BMD) and reducing fracture risk. The trial met all clinical endpoints, showing no clinically meaningful differences between the biosimilar and the reference product.

According to the announcement, CuraTeQ plans to begin regulatory submissions for BP16 in the EU, US, and other key regions from January 2026.

In April 2025, CuraTeQ reported successful Phase I results for BP16, which included 204 subjects from Australia and New Zealand, demonstrating comparable safety, pharmacodynamics and immunogenicity profiles to both the European and US versions of Prolia®.

European Commission Approves Shanghai Henlius/Organon’s Denosumab Biosimilars

Sep 19, 2025

On 19 September 2025, Shanghai Henlius and Organon announced that the European Commission has approved Bildyos® and Bilprevda® (HLX14), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively, for all reference indications.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Bildyos® and Bilprevda® in July 2025, following the acceptance of the marketing authorisation application by the European Medicines Agency in May 2024.

Shanghai Henlius entered into a licence agreement with Organon in June 2022 under which Organon has exclusive global commercialisation rights to HLX14 (denosumab) for all countries except China, Hong Kong, Macau and Taiwan.

In June 2025, Amgen sued Henlius and Organon in the US in relation to their denosumab biosimilars, alleging infringement of 26 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products. Amgen also has pending BPCIA litigation against Hikma/Gedeon Richter and Biocon in relation to denosumab. On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen was concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.

There are now 8 sponsors with denosumab biosimilars approved in the EU, although none have been launched to date, with previous approvals for: Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025) and Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025).

New Indication Alert: FDA Approves J&J’s Subcutaneous Guselkumab for UC

Sep 19, 2025

On 19 September 2025, Johnson & Johnson announced that the FDA has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC). The BLA for the SC regimen was accepted in November 2024 and followed the approval of Tremfya® with intravenous (IV) induction for UC in September 2024.

In March 2025, the FDA approved Tremfya® for the treatment of moderately to severely active Crohn’s disease in adults. With the latest approval, Tremfya® is the first and only IL-23 inhibitor to offer both SC and IV induction options for the treatment of UC and Crohn’s disease in the US.

Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease and UC in May 2025 and has been approved for the same indications in the EU (Crohn’s, May 2025; UC, April 2025).

Biosimilar development of guselkumab is underway. In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the Middle East and North Africa (MENA) region. In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

Celltrion’s Denosumab Biosimilars Second to be Approved in Canada

Sep 18, 2025

On 18 September 2025, Celltrion announced that Health Canada has granted approval for Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for all reference indications.

This makes Celltrion’s Stoboclo® and Osenvelt® the second pair of denosumab biosimilars approved in Canada, following Sandoz’s Wyost® (approved February 2024) and Jubbonti® (approved March 2024), which were launched in August 2024.

Celltrion’s denosumab biosimilars have been approved in various regions, including: Korea (approved November 2024, launched March 2025), Europe (approved February 2025, not yet launched), the US (approved March 2025, launched July 2025) and Australia (approved April 2025, not yet launched).

In May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab. That litigation settled in January 2025, supporting the US launch of Celltrion’s denosumab biosimilars in July 2025.

Samsung Bioepis’ Aflibercept Biosimilar Third to be Approved in Australia

Sep 18, 2025

OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial (456527)
OPUVIZ aflibercept 40 mg/mL solution for intravitreal injection in vial with needle (456528)

The PI for Opuviz® is not yet available.

With this approval, Samsung Bioepis becomes the third sponsor with an approved aflibercept biosimilar in Australia. Celltrion’s Eydenzelt® was the first aflibercept biosimilar TGA-approved on 31 March 2025 (solely for myopic CNV), which was followed by Sandoz’s Afqlir® and Enzeevu® on 27 May 2025. Sandoz’s products were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme with listing anticipated on 1 December 2025.

Aflibercept is currently the subject of patent infringement proceedings in Australia. On 8 September 2025, the Federal Court of Australia published a judgment refusing to award Regeneron and Bayer an interlocutory injunction against Sandoz to prevent the launch of Sandoz’s Afqlir®. Regeneron/Bayer filed an application for leave to appeal that decision on 17 September 2025. Regeneron/Bayer are separately seeking preliminary discovery from Sandoz in relation to a second Regeneron aflibercept patent, AU2020397865, which is scheduled for hearing on 6 November 2025.

Actor Pharmaceuticals, which does not yet have an aflibercept biosimilar approved in Australia, filed revocation proceedings against Regeneron and Bayer in the Australian Federal Court on 5 August 2025, seeking to invalidate AU2012205599, with a first case management hearing in that matter currently scheduled for 8 October 2025.

FDA Approves Biocon’s Denosumab Biosimilars Bosaya™ and Aukelso™

Sep 17, 2025

On 17 September 2025, Biocon Biologics announced that it received FDA approval for denosumab products Bosaya™ and Aukelso™, biosimilars to Amgen’s Prolia® and Xgeva®, respectively. The FDA granted provisional interchangeability designation for Bosaya™ and Aukelso™ for all approved indications.

Biocon’s denosumab biosimilars are the sixth pair to be approved in the US, following Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched).

In June 2025, Amgen sued Henlius and Organon in the US in relation to their denosumab biosimilars, alleging infringement of 26 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins, like denosumab, and denosumab products. Amgen also has pending BPCIA denosumab litigation against Hikma/Gedeon Richter and Biocon. On 16 July 2025, BPCIA litigation involving Accord/Intas and Amgen concluded following a settlement between the parties permitting Accord/Intas to launch its denosumab biosimilars in the US after 1 October 2025.