On 19 August 2025, CSPC Pharmaceutical announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection, biosimilar to Sanofi/Regeneron’s Dupixent®.  According to CSPC, the product, which is indicated for the treatment of moderate-to-severe atopic dermatitis in adults, has been demonstrated to be highly similar to Dupixent® in terms of quality, safety and efficacy in pharmaceutical and non-clinical studies.

There are a number of other dupilumab biosimilars under development.  In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.

Alvotech and Advanz entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries, with Alvotech responsible for development, and Advanz responsible for commercialisation.

On 25 June 2025, Bio-Thera Solutions, Ltd. and Costa Rican-based SteinCares announced that they have signed an agreement to commercialise biosimilar dupilumab across Latin America.  Under the agreement, Bio-Thera will be responsible for product development and supply, while SteinCares will lead the registration and commercialisation process throughout Latin America.

Bio-Thera’s BAT2406, biosimilar to Sanofi’s Dupixent® (dupilumab), is currently undergoing Phase I clinical trials.

This is the fourth product on which the companies have agreed to collaborate in the region.  An agreement was announced in March 2024 in relation to BAT2606, biosimilar to GSK’s Nucala® (mepolizumab) and BAT2506, biosimilar to J&J’s Simponi® and Simponi Aria® (golimumab).  The partnership was expanded in December 2024 to include a third undisclosed product.

On 18 April 2025, Sanofi and Regeneron announced that Dupixent (dupilumab) received FDA approval as the first new targeted therapy in over a decade for chronic spontaneous urticaria (CSU).  The FDA had accepted Sanofi/Regeneron’s resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent® (dupilumab) for the treatment of CSU in November 2024, with a target action date of 18 April 2025.

Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil.

On 28 March 2025, Sanofi and Regeneron announced that Japan’s Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorisation for Dupixent® (dupliumab) for the treatment of chronic obstructive pulmonary disease (COPD) in adults whose disease is not adequately controlled with existing therapy.

Dupixent® was approved in the US and China, and the UK, as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype in September 2024.

In July 2024, Dupixent® received European approval as an add-on maintenance treatment for adults with uncontrolled COPD, the first approval of Dupixent® for COPD anywhere in the world.

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for February 2025.  Among the applications to be reviewed is a new indication for MSD’s Keytruda® (pembrolizumab) for patients with head and neck squamous cell carcinoma (HNSCC) as a preliminary treatment prior to surgery or as a treatment in combination with radiotherapy followed by Keytruda® alone.

The TGA has also updated its online list of prescription medicine registrations, with new registrations for the following expanded indications:

• MSD’s Keytruda® in combination with chemoradiotherapy for treatment of patients with high-risk locally advanced cervical cancer (FIGO 2014 Stage IB1-IIB and node-positive, or Stage III-IVA) (3 March 2025) and in combination with Astellas Pharma’s Padcev® (enfortumab vedotin) for first-line treatment of adults with locally advanced or metastatic urothelial carcinoma (24 February 2025)
• AstraZeneca’s Imfinzi® (durvalumab) as monotherapy for the treatment of adults with limited stage small cell lung cancer whose disease has not progressed following chemoradiation therapy (27 February 2025);
• Sanofi’s Dupixent® (dupilumab) for chronic obstructive pulmonary disease (25 February 2025);
• Astellas’ Padcev® (enfortumab vedotin) as monotherapy for treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed dealth-ligand-1 inhibitor (17 February 2025); and
• Bristol-Myers Squibb’s Opdivo® (nivolumab), in combination with chemotherapy, for the neoadjuvant treatment of adults with resectable non-small cell lung cancer and no known EGFR mutations or ALK rearrangements, followed by Opdivo® as a single agent in the adjuvant setting after surgical resection (6 February 2025).

On 18 February 2025, Regeneron and Sanofi announced that the US FDA has accepted their sBLA for priority review of Dupixent® (dupilumab) for the targeted treatment of bullous pemphigoid (BP).  The FDA’s decision is expected by 20 June 2025.  If approved, Dupixent® will be the first and only targeted medicine to treat BP in the US.

The FDA is also reviewing a Dupixent® sBLA for chronic spontaneous urticaria (CSU), with action due on 18 April 2025.

Despite the appearance of “business as usual”, Regeneron’s litigation against Sanofi in the US District Court for the Southern District of New York remains on foot, in which Regeneron alleges Sanofi violated the terms of their Dupixent® collaboration agreement.

On 20 December 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its November 2024 meeting.

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS):

• Sandoz’s Wyost®, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab), for osteoporosis, giant cell tumour of bone, and bone metastases
• Celltrion’s Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, Crohn’s disease, complex refractory fistulising Crohn’s disease, and moderate to severe ulcerative colitis.

Among the originator biopharmaceuticals, Bayer secured a recommendation for its Eylea® (aflibercept) indication expansion for diabetic macular oedema and subfoveal choroidal neovascularisation secondary to age-related macular degeneration.  Novo Nordisk’s Ozempic® (semaglutide) also received a positive recommendation for type 2 diabetes mellitus, following its application for a new strength formulation.

Several oncology treatments received positive recommendations, including Janssen’s Rybrevant® (amivantamab) for non-small cell lung cancer.  Other cancer treatments recommended include Amgen’s Blincyto® (blinatumomab) for MRD-negative B-cell precursor acute lymphoblastic leukaemia, AstraZeneca’s Imfinzi® for use in combination with platinum-based chemotherapy for the treatment of deficient mismatch repair (dMMR) endometrial cancer, and Astellas Pharma’s Padcev® (enfortumab vedotin) for locally advanced or metastatic urothelial cancer.

AbbVie’s Epkinly® (epcoritamab) received a recommendation for relapsed or refractory diffuse large B-cell lymphoma, while Novartis’ Aimovig® (erenumab) was recommended for chronic migraine.

For hereditary angioedema, both CSL’s garadacimab and Takeda’s Takhzyro® (lanadelumab) secured positive recommendations.

Additional recommendations were granted to BMS’s Opdivo® (nivolumab) for urothelial carcinoma, MSD’s Keytruda® (pembrolizumab) for renal cell carcinoma, and Alexion Pharmaceuticals’ Ultomiris® (ravulizumab) for Neuromyelitis Optica Spectrum Disorder.

BeiGene’s Tevimbra® (tislelizumab) also received a positive recommendation for oesophageal squamous cell carcinoma.

The PBAC reports that some earlier recommendations have been extended:

• Sanofi’s Dupixent® (dupilumab) for chronic severe atopic dermatitis and uncontrolled severe asthma

Additionally, two recommendations have been rescinded:

• Celltrion Remsima SC® (infliximab) for rheumatoid arthritis
• AbbVie’s Skyrizi® (risankizumab) for Crohn’s disease

The Australian Government has reached an agreement with Sanofi and Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) to ensure Dupixent® (dupilumab) remains listed on the Pharmaceuticals Benefits Scheme (PBS) for eczema treatment, as it has been since 2021.  In July 2024, higher than expected prescription numbers had risked Dupixent® being withdrawn from the PBS.  Eczema Support Australia lobbied in support of the continued listing and has welcomed the decision.

Dupixent® will be considered in March 2025 for PBS listing for severe atopic dermatitis and uncontrolled severe asthma.

On 28 November 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the March 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.  This follows the PBAC’s publication of its September 2024 intracycle meeting outcomes, which noted that, to date, it had not received an acceptable proposal for an expanded listing to facilitate broad access to PD-(L)1 inhibitors which includes MSD’s pembrolizumab and BMS’ nivolumab.   

For the March 2025 agenda, half of the submissions selected for consideration are for monoclonal antibodies, 17 of which are list for new PBS additions and 6 for amendments. 

Four biosimilars will be considered for new listings: 

• Pfizer’s Ixifi®, biosimilar to Janssen’s Remicade® (infliximab), for severe active rheumatoid arthritis, ankylosing spondylitis, severe psoriatic arthritis, severe chronic plaque psoriasis, severe Crohn disease, complex refractory fistulising Crohn Disease, and moderate to severe ulcerative colitis 

• Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), for relapsing-remitting multiple sclerosis 

• Celltrion’s Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab), for uncontrolled severe asthma, uncontrolled severe allergic asthma, and severe chronic spontaneous urticaria 

• Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, severe Crohn disease, and complex refractory fistulising Crohn Disease 

One biosimilar is being considered for changes to an existing listing: Celltrion’s Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab). 

Other applications for PBS listing additions or amendments that the PBAC will consider at its March 2025 meeting include the following: 

On 21 November 2024, Replimune announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec, a genetically modified oncolytic strain of HSV-1 virus) in combination with Opdivo® (nivolumab) for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen.  The submission was made under the Accelerated Approval pathway.  The Company also announced that the FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting. 

Opdivo® is was approved in Europe in August 2023 for treatment of melanoma as monotherapy.