On 8 January 2026, the Munich Regional Court granted Regeneron and Bayer preliminary injunctions (PIs) preventing STADA, Hexal, Celltrion and Advanz Pharma from marketing their aflibercept biosimilars in Germany and requiring them to recall any products already on the market.  According to a Juve Patent report, while the PI against STADA, Hexal and Celltrion is limited to Germany, the PI against Advanz covers 21 countries.

The Court’s rulings are based on Regeneron’s patent, EP 2 364 691, relating to a formulation of aflibercept, the active ingredient of Regeneron/Bayer’s Eylea®.

The biosimilars restrained by the PIs granted by the Court are as follows:

• Afqlir®, a product of the Sandoz Group, of which Hexal is a part in Germany. Afqlir® was EU-approved in November 2024 and was launched in the UK in November 2025.  At the time of the UK launch, Sandoz announced that launches in major European markets such as Germany and France would follow, with additional European rollouts to occur in 2026;
• Celltrion’s Eydenzelt® (CT-P42), which received European approval in February 2025;
• Advanz’s Mynzepli®, which was approved in Europe in August 2025. Mynzepli® (AVT06) was developed by Alvotech and, under a June 2024 agreement, Advanz has the exclusive commercialisation rights to the product throughout Europe, except in Germany and France, where the rights are semi-exclusive; and
• STADA’s Afiveg®, which was EU approved in September 2025.

Celltrion has subsequently announced that it is “actively pursuing patent agreements” with Regeneron/Bayer in relation to aflibercept, including in Germany, in order to “quickly introduce the product to the market”.

The successful PI applications by Regeneron/Bayer in Germany follow a PI granted by the same German court in September 2025, with a permanent cross-border injunction granted in October 2025, preventing Formycon from launching its aflibercept biosimilar, FBY203 (Baiama®/Ahzantive®), in multiple European countries.  Formycon has lodged an appeal.

In November 2025, Alvotech succeeded in defending Regeneron/Bayer’s request for an injunction from the UK High Court to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Mynzepli® (AVT06) (aflibercept).  This ruling cleared 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 1 183 353 (encompassing aflibercept) on 23 November 2025.

On 19 December 2025, Alvotech and Teva jointly announced that they have reached a settlement and licence agreement with Regeneron regarding the US launch of Alvotech’s AVT06, biosimilar to Regeneron’s Eylea® (aflibercept).  Under the agreement, Alvotech/Teva are permitted to launch AVT06 in Q4 of 2026, or earlier under certain undisclosed circumstances.

A Biologics Licence Application for AVT06 was accepted by the FDA for review in February 2025.  By way of a partnership commenced in August 2020, Teva holds the US commercialisation rights for AVT06.

Only a single biosimilar competitor to Regeneron’s Eylea® is currently on the market in the US; Amgen’s Pavblu®, launched October 2024.  However, there are a number of approved aflibercept biosimilars, some of which have scheduled 2026 launch dates as a result of litigation settlements: Biocon’s Yesafili® (approved May 2024, due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026) and Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026).  A preliminary injunction was granted, and remains in place, preventing Samsung Bioepis’ US launch of Opuviz® (14 June 2024, upheld on appeal on 29 January 2025).

AVT06 was approved in the EU and UK in August 2025, as Mynzepli®, and in Japan in September 2025.

In November 2025, Alvotech succeeded in defending Regeneron/Bayer’s request for an injunction from the UK High Court to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to AVT06.  This ruling cleared 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.

On 18 December 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) November 2025 meeting were published, including recommendations for the listing of three Celltrion biosimilars on the Pharmaceutical Benefits Scheme (PBS):

• Eydezenlt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg);
• Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab); and
• Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab).

Celltrion’s 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, though have not yet been listed.

In December 2025, Regeneron/Bayer and Sandoz settled all Australian aflibercept patent infringement/revocation proceedings, with the terms of the settlement not otherwise being disclosed.  Regeneron/Bayer are defending pending revocation proceedings commenced by Actor Pharmaceuticals in August 2025 and have cross-claimed for infringement.

In addition to Celltrion’s Stoboclo® and Osenvelt® (approved April 2025), there are three other sponsors with denosumab biosimilars approved in Australia:  Sandoz’s Jubbonti® and Wyost® (August 2024), Samsung Bioepis’ Ospomyv® and Xborso® (July 2025) and Accord’s Denolia™/Deskeltia™ and Dostiva™/Dexeva™ (October 2025).  On 1 August 2025, Sandoz’s Jubbonti® and Wyost® became the first biosimilars to Amgen’s Prolia® and Xgeva® to be PBS-listed.  In April 2025, Amgen commenced Court proceedings in Australia seeking preliminary discovery of documents from Sandoz in relation to its denosumab biosimilars.  That proceeding concluded and Amgen commenced patent infringement litigation against Sandoz in the Federal Court of Australia in June 2025.

Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and to be considered (and now recommended) for PBS-listing.

On 16 December 2025, Celltrion announced that it has launched Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in major European countries, including Germany, Portugal and the UK.

Eydenzelt® received European approval in February 2025 for the treatment of multiple retinal disorders, including nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV).

The launch of Eydenzelt® is the second European launch of an aflibercept biosimilar to be announced following the 23 November 2025 expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept).  Sandoz’s Afqlir® was the first aflibercept biosimilar to be launched in the UK in late November 2025.

On 13 December 2025, Biocon Biologics announced that it had reached a settlement and licence agreement with Regeneron and Bayer for Yesafili® (aflibercept) in Europe (and ROW), enabling Biocon to launch Yesafili® in the UK in January 2026 and ROW in March 2026, or earlier under certain undisclosed circumstances.  A settlement covering the US and Canada was previously agreed between the companies in April 2025, permitting a US launch in H2 2026.

Other aflibercept biosimilars currently approved in Europe include Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025) and Alteogen’s Eyluxvi® (September 2025).

Litigation will continue to hold up European launches for some biosimilar sponsors.  For example, in October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction preventing Formycon’s launch of its aflibercept biosimilar in 20 countries.  The Hague District Court also granted an injunction in October 2025 preventing Samsung Bioepis from launching its aflibercept biosimilar in the Netherlands.

The news has been better for aflibercept biosimilars in the UK, with Samsung Bioepis and Formycon/Klinge defeating injunction applications by Regeneron/Bayer in relation to their aflibercept biosimilars in October 2025.  In early November 2025, the UK High Court rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s Mynzepli®.

On 13 December 2025, Biocon Biologics announced that it has reached a settlement and licence agreement with Regeneron and Bayer for Yesafili®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) in Europe and ROW, enabling Biocon to launch Yesafili® in the UK in January 2026 and ROW in March 2026, or earlier under certain undisclosed circumstances.  The settlement follows an April 2025 settlement between the companies covering the US and Canada, which paves the way for a US launch of Yesafili® in H2 2026.

Yesafili® was the first aflibercept biosimilar to receive European marketing approval in September 2023, following a positive CHMP opinion in July 2023.  It was approved in the UK in November 2023.

Sandoz’s Afqlir® was the first aflibercept biosimilar to launch in the UK on 24 November 2025, following the 23 November 2025 expiry of Regeneron’s SPC on European patent EP 1183353 (encompassing aflibercept).  At the time, Sandoz announced the launches in major European markets such as Germany and France would follow, with additional European rollouts to occur in 2026.

Other aflibercept biosimilars currently approved in Europe include 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).

Litigation will continue to hold up European launches for some biosimilar sponsors.  For example, in October 2025, the Munich Regional Court granted Regeneron a permanent cross-border injunction preventing Formycon’s launch of its aflibercept biosimilar in 20 countries.  The Hague District Court also granted an injunction in October 2025 preventing Samsung Bioepis from launching its aflibercept biosimilar in the Netherlands.

The news has been better for aflibercept biosimilars in the UK, with Samsung Bioepis and Formycon/Klinge defeating injunction applications by Regeneron/Bayer in relation to their aflibercept biosimilars in October 2025.  In early November 2025, the UK High Court rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s Mynzepli®.

At its December 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended indication extensions for a number of biopharmaceuticals.

Among these, Regeneron/Bayer’s Eylea® 8mg (aflibercept) 114.3 mg/ml solution for injection) was recommended for the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch, central and hemiretinal RVO).  Once approved by the European Commission, this will be the third indication for the high dose form of Eylea®, which was previously approved in the EU in January 2024 for treatment of nAMD and diabetic macular oedema.  Eylea HD® (as the 8mg product is known in the US) was FDA approved for the RVO indication in November 2025.

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

This month, the CHMP has also adopted a positive opinion for Janssen’s Simponi® (golimumab), for the treatment of paediatric ulcerative colitis.  The CHMP decision follows the FDA’s approval of the same indication in October 2025.

Alvotech/Advanz’s Gobivaz® was the first and only EU golimumab biosimilar approved in Europe in November 2025.  However, Bio-Thera/STADA’s Gotenfia®/BAT2506 is following closely behind, with a positive CHMP opinion for the biosimilar adopted at the December 2025 EMA meeting.

Other biopharmaceuticals to receive CHMP recommendations at the December 2025 meeting are:

• GSK’s Nucala® (mepolizumab), for chronic obstructive pulmonary disease (COPD); and
• Amgen’s Uplizna® (inebilizumab), for neuromyelitis optica spectrum disorders (NMOSD).

On 5 December 2025, Korea’s HIT News reported that Samsung Bioepis has successfully overturned a preliminary injunction granted to Regeneron and Bayer which was preventing Korean sales of Samsung Bioepis’ Afilivu® (SB15), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).

The ruling of the Seoul High Court’s Civil Division, finding in favour of Samsung Bioepis, follows an October 2025 decision of the Korean Patent Court invalidating a Regeneron patent for ophthalmic formulations of aflibercept (the Korean equivalent to US Patent No. 11,084,865).

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.  However, that launch was disrupted by the preliminary injunction.  Following the appeal decision, Samsung Bioepis/Samil can now resume distribution of Afilivu® in Korea.

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 3 December 2025, Fresenius Kabi announced that the FDA has accepted for review Sam Chun Dang’s (SCD) application for its biosimilar aflibercept, SCD411.  Under a December 2024 licensing agreement between Fresenius Kabi and SCD, Fresenius has the exclusive rights to commercialise the South Korean developed SCD411, biosimilar to Regeneron’s Eylea® (aflibercept), in the United States, Brazil, Argentina, Chile, Paraguay, Colombia, and Mexico.

SCD411 was approved in vial and pre-filled syringe (PFS) forms in Japan and Korea in September 2025, in Canada in June 2025 and in Europe in August 2025.  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.

On 14 July 2025, Fresenius Kabi filed petitions for IPR (inter partes review) against Regeneron’s US Patent No. 11,084,865 to ophthalmic formulations of aflibercept and US Patent No. 10,828,345 to methods of treating angiogenic eye disorders.  Fresenius is seeking to overturn claims 1-5, 7-30, and 32-50 of the 865 patent based on anticipation, and all claims of the 345 patent based on anticipation and obviousness.  In November 2025, the PTAB denied institution of the IPR regarding the ‘865 patent on discretionary grounds (without reasons).  Fresenius Kabi has sought review of that denial by way of a request filed in December 2025.  The IPR regarding the ‘345 patent remains pending.

Regeneron/Bayer and Sandoz have settled Australian aflibercept patent infringement/revocation proceedings, with the Federal Court of Australia on 27 November 2025 dismissing all related proceedings by consent (VID715/2025; VID968/2025; VID1234/2025).  The terms of the AU settlement have not otherwise been disclosed.

Regeneron and Bayer commenced proceedings against Sandoz on 4 June 2025 alleging infringement of Regeneron’s patent AU2012205599 relating to methods of treatment for angiogenic eye disorders, and separately sought preliminary discovery from Sandoz in relation to a second Regeneron aflibercept formulation/process patent, AU2020397865.

Regeneron/Bayer sought both a preliminary injunction (PI or interlocutory injunction) and final relief in respect of AU599, and Sandoz cross-claimed for invalidity.  The PI application was heard on 14 August 2025 with Justice Rofe publishing her reasons for judgment on 8 September 2025, rejecting Regeneron/Bayer’s application.  Rofe J found there was an “insufficient likelihood of success” that Regeneron/Bayer’s infringement case would succeed at a final hearing and that the balance of convenience did not favour the grant of the interlocutory injunction.

Regeneron moved swiftly to appeal her Honour’s decision, with the Full Court hearing the appeal on 29 October 2025.  However, the proceedings were settled the day that judgment was due to be delivered, with no decision being handed down.

Regeneron and Bayer’s ‘599 patent remains the subject of revocation proceedings in Australia.  In August 2025, Actor Pharmaceuticals, which does not yet have any aflibercept biosimilar approved in Australia, filed proceedings in the Federal Court seeking to invalidate AU599, with the first case management hearing in that matter heard on 2 December 2025.  In that first case management hearing, Regeneron’s counsel represented that it is also considering whether to involve the ‘865 patent and bring preliminary discovery proceedings.  Actor’s aflibercept product remains under evaluation by the TGA and is not yet approved.

On 9 September 2025, Sandoz announced that it settled all US patent disputes between it and Regeneron relating to Sandoz’s Enzeevu® (aflibercept).  Under the terms of the US settlement, Sandoz is permitted to launch its biosimilar aflibercept in the US in Q4 2026, or earlier in certain undisclosed circumstances.

On 28 November 2025, Celltrion announced that Health Canada has approved its Eydenzelt®, biosimilar to Regeneron’s Eylea® (aflibercept), for all reference indications, in vial and pre-filled syringe forms.

Eydenzelt® is approved in a number of other regions, including in the US (October 2025), EU (February 2025) and Korea (May 2024).  In Australia, Eydenzelt® was approved solely for myopic CNV in March 2025, however, in July 2025, Celltrion filed an application with the TGA to expand Eydenzelt®’s indications to all those of Eylea®.  Eydenzelt® was considered for reimbursement at the November 2025 meeting of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC), though the outcome has not yet been published.

The Canadian approval strengthens Celltrion’s position in North America following the settlement of US BPCIA litigation between Regeneron and Celltrion in relation to Eydenzelt® in October 2025, the terms of which permit Celltrion to launch Eydenzelt® in the US on 31 December 2026.

Launches of other US-approved aflibercept biosimilars have been delayed by BPCIA litigations brought by Regeneron.  However, the following proceedings have 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 settlements 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).