On 10 November 2025, Alvotech announced that the UK High Court has rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s AVT06 (Mynzepli®), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).

The ruling clears the way for pre SPC expiry UK manufacturing activities to progress enabling the “day 1” (post SPC expiry) launch of AVT06 in the UK, Europe and other countries following the expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept) on 23 November 2025.

Regeneron/Bayer commenced the legal proceedings against Alvotech and its UK contract manufacturing organisation (CMO), Fisher Clinical Services, in September 2025.  The case focused on the operation of the SPC Manufacturing Waiver, which exempts third party manufacturing activities from patent infringement on certain conditions, including regarding notification to the patent holder.

Regeneron/Bayer argued that Alvotech’s UK waiver notice was deficient in that it had not identified details of the country of export at the time of providing the waiver notice.  Justice Meade of the UK High Court rejected this argument from the bench during the hearing on 4 November 2025 (with judgment to be subsequently published).

As a result, Alvotech and Fisher can continue to manufacture and store AVT06 in the UK pre SPC expiry, for distribution in the UK, to EEA and ROW.

Mynzepli® was approved by the European Commission in August 2025 across all Eylea® indications, in pre-filled syringe and vial presentations, following a positive CHMP opinion in June 2025.  The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved AVT06 on 28 August 2025.

Alvotech has partnered with Advanz Pharma for the commercialisation of Mynzepli® in the UK and Europe.  Under a June 2024 agreement, Advanz Pharma has exclusive commercialisation rights throughout Europe, except in Germany and France, where the rights are semi-exclusive.

On 1 November 2025, HITNews reported that Samsung Bioepis has overturned a 2024 decision of the Korean Intellectual Property Trial and Appeal Board (IPTAB) which found that a Regeneron patent for ophthalmic formulations of aflibercept (the Korean equivalent to US Patent No. 11,084,865) was valid.  The Korean patent has now been invalidated by the First Division of the Korean Patent Court.  An injunction granted in May 2025 based on the patent, preventing Korean sales of Samsung Bioepis’ Afilivu® (SB15), biosimilar to Regeneron’s Eylea® (aflibercept), is expected to be lifted.

This latest success for Samsung Bioepis follows a ruling in its favour by the Seoul Central District Court in February 2025, in a proceeding commenced by Regeneron in January 2023 seeking to prevent Samsung Bioepis from producing and selling Afilivu® in Korea.

Afilivu® was the first aflibercept biosimilar approved in Korea in February 2024.  In April 2024, it was reported that Samil Pharmaceutical would launch Samsung Bioepis’ aflibercept biosimilar in the Korean market from 1 May 2024.

On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Samsung Bioepis from launching its aflibercept biosimilar in the US without a licence from Regeneron.  This ruling affirmed an earlier decision of the US District Court for the Northern District of West Virginia in June 2024, finding that Samsung Bioepis infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.

On 29 October 2025, Samsung Bioepis announced that it has entered into an Asset Purchase Agreement with Biogen in Europe for Samsung Bioepis’ two ophthalmology biosimilars: Byooviz® (biosimilar to Genentech’s Lucentis® (ranibizumab)) and Opuviz™ (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)).

Samsung Bioepis and Biogen had partnered in November 2019 in relation to commercialisation of the two ophthalmology biosimilars in the US, Canada, Europe, Japan and Australia.  In October 2024, Biogen decided to terminate the November 2019 agreement with Samsung Bioepis within the US and Canada.  In July 2025, Samsung Bioepis entered into an agreement with Harrow, under which Harrow will assume full commercial responsibility for Byooviz® and Opuviz™ in the US upon full transition of Biogen’s commercialisation rights back to Samsung Bioepis by the end of 2025.

Under the Asset Purchase Agreement announced this week, Samsung Bioepis will be responsible for commercialising Byooviz® in Europe from January 2026 once the transfer of commercial rights from Biogen back to Samsung Bioepis takes effect.  Samsung Bioepis will launch Opuviz™ in Europe following the lapse or revocation of relevant patent(s) for Eylea®.

Byooviz® has been commercially available in several European countries since March 2023, following its approval in August 2021 as the first ophthalmology biosimilar in the region for the treatment of patients with nAMD, macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularisation (mCNV).  Other EU approved ranibizumab biosimilars include Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva), Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (approved November 2022).

There are currently 10 aflibercept biosimilars approved in Europe:  Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025) and Alteogen’s Eyluxvi® (September 2025).  Sam Chun Dang announced on 20 August 2025 that its aflibercept biosimilar received EU marketing authorisation, although the name of the product is not yet known.

On 27 October 2025, the FDA issued a Complete Response Letter (CRL) to Regeneron for its pre-filled syringe (PFS) supplementary BLA (sBLA) for Eylea HD® (aflibercept, 8mg).  The only issue cited in the CRL relates to unresolved inspection findings at Catalent, the manufacturer filler included in the sBLA.  On 9 October 2025, Catalent received an “official action indicated” classification from the FDA, indicating that it is in an “unacceptable state of compliance” after an FDA inspection.  Regeneron intends to submit an application to the FDA to include an additional PFS manufacturing filler in the Eylea HD® BLA by January 2026.

Regeneron’s Eylea HD® (aflibercept, 8mg) is already approved in the US in a vial form for nAMD, DME and diabetic retinopathy (August 2023).  Regeneron has also filed an sBLA in the US for the use of Eylea HD® to treat macular oedema following retinal vein occlusion (RVO) and for an extension of the dosing schedule to include every 4-week dosing across approved indications.  Regeneron has submitted an application to include an additional vial filler, with an FDA decision regarding this new vial filler expected by late December 2025.

Eylea® 8mg for intravitreal injection is approved for nAMD and DME including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024).  Eylea® 8mg pre-filled syringe (OcuClick) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025).  In addition to the US application, Regeneron/Bayer have submitted marketing authorisation applications for Eylea® 8mg for the treatment of patients with macular oedema following RVO in Japan (May 2025) and Europe (April 2025).

Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea® 8mg.  Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US.  In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 (and AVT06) in Europe.

On 24 October 2025, IAM reported that the Munich Regional Court has granted Regeneron a permanent cross-border injunction against Formycon preventing launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), across 20 countries.  The permanent injunction follows a cross-border preliminary injunction granted by the Court in September 2025, based on a finding of infringement by equivalence of Regeneron’s formulation patent, EP 2364691.

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 having been conducted in the US, UK, Italy, Belgium, the Netherlands, and France.  In the US, FYB203 is set to launch in Q4/2026 following settlement of BPCIA litigation between Formycon and Regeneron in October 2025.  Formycon may launch FYB203 in the UK in November 2025, following a February 2025 approval by the MHRA and a failed UK preliminary injunction application by Regeneron in October 2025 (subject to any appeal).

On 20 October 2025, Regeneron announced that it has settled its BPCIA litigation with Celltrion in relation to Eydenzelt®/CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg).  Under the terms of the settlement, Celltrion is permitted to launch Eydenzelt® in the US on 31 December 2026.

The settlement follows FDA approval of Eydenzelt® on 10 October 2025.  This was the sixth aflibercept biosimilar to be approved in the US following: Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu® (August 2024) Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Biocon’s Yesafili™ (May 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024).

Amgen’s Pavblu® is the only aflibercept biosimilar to have launched in the US, in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu® (June 2025), which remains pending.

Launches of other US-approved aflibercept biosimilars have been delayed by BPCIA litigation brought by Regeneron.  However, in addition to the Regeneron/Celltrion proceedings, the following litigation has now settled, with biosimilar launches scheduled for 2026:

• Biocon and Regeneron settled BPCIA litigation in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026 (or earlier under certain undisclosed circumstances); and
• Sandoz’s Enzeevu™ and Formycon’s Ahzantive® are set to launch in Q4/2026 (or earlier under certain undisclosed circumstances) after settlement and licence agreements were announced in September 2025 and October 2025, respectively.

A preliminary injunction was granted, and remains in place, preventing Samsung Bioepis’ US launch of biosimilar aflibercept (14 June 2024, upheld on appeal on 29 January 2025).

On 16 October 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), has entered exclusive licence agreements with Actor Pharmaceuticals and Uruguay-based Megalabs S.A. for the commercialisation of FYB203 in Australia and Latin America, respectively.

Under the agreements, Klinge is eligible to receive upfront and milestone payments and royalties on net sales.  Formycon will participate in all payment streams to Klinge, in the mid-single digit to low-double digit percentage range and will receive additional payments for organising the commercial market supply on behalf of Klinge.

According to Formycon, a regulatory application for FYB203 has been submitted to the Australian Therapeutic Goods Administration (TGA), while Formycon is working closely with Megalabs to prepare marketing applications for Latin American countries.

The agreements follow semi-exclusive commercialisation agreements between Klinge and Horus Pharma (September 2025) and Klinge and Teva Pharmaceuticals (January 2025) for FYB203, covering major parts of Europe (excluding Italy) and Israel.  Horus will market the product as Baiama®, while Teva will market it as Ahzantive®.  In June 2025, Klinge entered an exclusive licence agreement with Valorum for commercialisation of FYB203 in the US and Canada.

FYB203/Ahzantive® was approved by the FDA in June 2024 and is set to launch in the US in Q4/2026 following settlement of BPCIA litigation between Formycon and Regeneron in October 2025.  The biosimilar may launch in the UK in November 2025, following a February 2025 approval by the MHRA and a failed UK preliminary injunction bid by Regeneron in October 2025 (which is subject to any appeal).  The situation is less clear in Europe, where, on 25 September 2025, the Munich Regional Court granted Regeneron and Bayer a cross-border preliminary injunction (PI) preventing Formycon from launching FYB203 in a number of European countries, including Germany.  FYB203 received European marketing approval in January 2025 as Baiama® and Ahzantive®.

On 13 October 2025, Regeneron announced that it has been notified by Catalent Indiana, LLC, which was acquired by Novo Nordisk and is the manufacturer filler included in the supplemental BLA for Regeneron’s high dose (8mg) formulation of Eylea® (aflibercept), that Catalent received an “official action indicated” classification from the FDA on 9 October 2025.  This classification indicates that the facility is in an “unacceptable state of compliance” after an FDA inspection.

Regeneron’s Eylea HD® (aflibercept, 8mg) is already approved in the US in a vial form for nAMD, DME and diabetic retinopathy (August 2023).  However, Regeneron has filed an sBLA in the US for the use of Eylea HD® to treat macular oedema following retinal vein occlusion (RVO) and for an extension of the dosing schedule to include every 4-week dosing across approved indications.  Regeneron has also filed a US regulatory submission for Eylea HD® in a pre-filled syringe.

In August 2025, the FDA extended its target action date for these regulatory submissions (to Q4/2025) as a result of FDA observations based on an inspection at Novo Nordisk’s Catalent filling site.

According to Regeneron, while Catalent continues to work with the FDA to resolve the outstanding compliance issues, within the next 3 months, Regeneron is planning to submit an application to the FDA to include an additional manufacturing filler in the Eylea HD® BLA.

Eylea HD® (known as Eylea™ 8mg in Europe) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Eylea® 8mg for intravitreal injection is approved for nAMD and DME including in the EU (January 2024), Japan (January 2024), UK (January 2024) and Australia (June 2024).  Eylea® 8mg pre-filled syringe (OcuClick) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025).  In addition to the US application, Regeneron/Bayer have submitted marketing authorisation applications for Eylea® 8mg for the treatment of patients with macular oedema following RVO in Japan (May 2025) and Europe (April 2025).

Alvotech is developing AVT29, a biosimilar to Regeneron’s Eylea® 8mg.  Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2mg) in the US.  In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 (and AVT06) in Europe.

On 10 October 2025, Celltrion announced that the FDA has approved Eydenzelt® (CT-P42), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), for treating nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy.  The launch date for the product remains uncertain given pending BPCIA litigation brought by Regeneron against Celltrion regarding Eydenzelt®.

Eydenzelt® is the sixth aflibercept (2mg) biosimilar to be approved in the US following: Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu™ (August 2024) Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Biocon’s Yesafili™ (May 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024).

Amgen’s Pavblu® is the only aflibercept biosimilar to have launched in the US, in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen.  Regeneron has since commenced new BPCIA litigation against Amgen for Pavblu™ (June 2025), which remains pending.

Launches of other US-approved aflibercept biosimilars have been delayed by BPCIA litigation brought by Regeneron.  However, the following proceedings have now settled, with biosimilar launches scheduled for 2026:

• Biocon and Regeneron settled BPCIA litigation in April 2025, paving the way for a US launch of Yesafili™ in the second half of 2026 (or earlier under certain undisclosed circumstances); and
• Sandoz’s Enzeevu™ and Formycon’s Ahzantive® are set to launch in Q4/2026 (or earlier under certain undisclosed circumstances) after settlement and licence agreements were announced in September 2025 and October 2025, respectively.

Preliminary injunctions were granted, and remain in place, preventing US biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025).

Eydenzelt® was the fifth approved aflibercept biosimilar in Europe, in February 2025 (but has not yet launched), and received Korean approval in May 2024.  In Australia, Eydenzelt® was approved solely for myopic CNV on 31 March 2025.  However, in July 2025, Celltrion filed an application with the TGA to expand Eydenzelt®’s indications to all those of Eylea®.  Eydenzelt® will be considered for reimbursement at the November 2025 meeting of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC).

On 9 October 2025, New Zealand’s Medsafe approved Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept 2mg), in vial and pre-filled syringe presentations, making Afqlir® the first aflibercept biosimilar approved in New Zealand.

Sandoz’s aflibercept biosimilars have received approval in a number of jurisdictions, including the US (August 2024, as Enzeevu®), the EU (November 2024, as Afqlir®), and Australia (May 2025, as Afqlir® and Enzeevu®).  Afqlir® and Enzeevu® were the first aflibercept biosimilars to be considered and recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS), 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 6 November 2025.