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 7 November 2025, Medical Dialogues reported that Zydus Lifesciences has received tentative approval from the FDA for olaparib tablets, 100 mg and 150 mg, referencing AstraZeneca/MSD’s Lynparza®.

In February 2025, AstraZeneca and MSD’s Lynparza® was accepted in Scotland for reimbursement for the treatment of adults with BRCA1 or 2 mutated HER2-negative advanced breast cancer, who have already received appropriate treatments for their type of breast cancer.

In December 2024, AstraZeneca and MSD announced positive results for Lynparza® in the treatment of breast cancer, demonstrating a reduced risk of death by 28%.

On 7 November 2025, Boan Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorisation applications (MAAs) for two denosumab injections: 60mg (BA6101; biosimilar to Amgen’s Prolia®) and 120mg (BA1102; biosimilar to Amgen’s Xgeva®).

There are five sponsors with denosumab biosimilars approved in the UK, including: Sandoz’s Wyost® and Jubbonti® (November 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (March 2025), Celltrion’s Stoboclo® and Osenvelt® (May 2025), Accord’s Osvyrti® (June 2025) and Biocon’s Evfraxy® and Vevzuo® (July 2025).

Boan Biotech’s denosumab biosimilars have previously been approved in China in 2024 (Boluojia®; BA11021) and 2022 (Boyoubei®; BA6101).

On 6 November 2025, Hikma Pharmaceuticals announced its US launch of Starjemza™, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  This is the first biosimilar Hikma has launched in the US.

Starjemza™ was approved by the FDA in May 2025.  It is commercialised in the US by Hikma under an exclusive commercialisation and licence agreement with Bio-Thera entered in August 2021.  Bio-Thera remains responsible for the development and manufacture of the product.

Other ustekinumab biosimilars launched in the US to date are: Amgen’s Wezlana® (January 2025), Alvotech/Teva’s Selarsdi® (February 2025), Samsung Bioepis/Sandoz’s Pyzchiva® (February 2025), Biocon’s Yesintek® (February 2025), Formycon/Fresenius Kabi’s Otulfi® (March 2025) and Celltrion’s Steqeyma® (March 2025).

On 6 November 2025, Samsung Bioepis announced that it has signed a settlement and licence agreement with Johnson & Johnson (J&J) in relation to the European commercialisation of Pyzchiva® (SB17), biosimilar to Stelara® (ustekinumab).

While the terms of the agreement are confidential, the settlement is expected to resolve a pending Dutch Supreme Court appeal in relation to Janssen’s Supplementary Protection Certificate (SPC) for EP 1 309 692 B1 regarding ustekinumab.  The appeal followed an April 2025 SPC Waiver ruling of the Hague Court of Appeal upholding an earlier decision that Samsung Bioepis did not infringe the SPC by manufacturing and stockpiling Pyzchiva® for export outside the European Union.

The parties have been involved in a number of disputes regarding the validity of Janssen’s European patents for ustekinumab, including EP 3883606, relating to the use of ustekinumab for treating ulcerative colitis.  In September 2025, the District Court of The Hague held that the Dutch equivalent of the patent was valid.  A year earlier, in September 2024, Justice Meade of the High Court of Justice of England and Wales refused Janssen leave to appeal from an earlier decision that the UK counterpart of the patent was invalid.  Samsung Bioepis’ opposition to EP 3883606 in the European Patent Office was discontinued on 3 November 2025, after Samsung Bioepis formally withdrew it.

Pyzchiva® is commercialised by Sandoz in EEA, Switzerland, UK, US and Canada pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.  Pyzchiva® was approved by the European Commission in April 2024, and was launched by Sandoz in Europe in July 2024.

Samsung Bioepis and J&J settled US litigation regarding ustekinumab in 2023, permitting Samsung Bioepis/Sandoz to commercialise Pyzchiva® in the US in February 2025.

On 6 November 2025, Alvotech and Advanz Pharma announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Gobivaz® (AVT05), biosimilar to J&J’s Simponi® (golimumab).  The approval covers both pre-filled syringe and autoinjector dosage forms (50 mg/0.5 mL and 100 mg/mL) of Gobivaz®, which is indicated for rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis in adults and juvenile idiopathic arthritis.

Gobivaz® is being commercialised by Advanz in the UK and Europe under a May 2023 licence and supply agreement with Alvotech, which is responsible for development and commercial supply of the product.

AVT05 was the first golimumab biosimilar to be approved worldwide, with its September 2025 approval in Japan, where it is being commercialised by Fuji Pharma.  Also in September 2025, Gobivaz® received a positive opinion from the European Medicine Agency’s CHMP, after Alvotech/Advanz’s European MAA for that product was the first golimumab biosimilar MAA to be accepted anywhere in the world (November 2024).

In the US, Alvotech/Teva’s Biologics Licence Application (BLA) for AVT05 was accepted by the FDA in January 2025.  The FDA issued a Complete Response Letter in relation to the BLA in early November 2025, with Alvotech working to resolve “certain deficiencies” identified following a manufacturing facility inspection.

A golimumab biosimilar, BAT2506, is also being developed by Bio-Thera, with an MAA for the product accepted in Europe in February 2025 (where it is being commercialised by STADA under a May 2024 agreement), and a BLA accepted for FDA review in July 2025 (with Accord responsible for US commercialisation).  Bio-Thera has also entered into commercialisation agreements for BAT2506 with SteinCares for Latin America (March 2024) and Dr Reddy’s for South East Asia (March 2025).

On 6 November 2025, Amgen filed two separate BPCIA litigation suits in the US District Court for the District of New Jersey, against each of Dr Reddy’s/Alvotech and Amneal/mAbxience, asserting infringement of 31 US patents covering denosumab, pharmaceutical compositions of denosumab, methods of manufacturing therapeutic proteins like denosumab, and denosumab products.

The litigation follows the FDA’s March 2025 acceptance for review of both Alvotech/Dr Reddy’s Biologics Licence Application (BLA) for AVT03 and Amneal/mAbxience’s BLA for its denosumab biosimilars (MB09).

Under a partnership announced in October 2023, Amneal/mAbxience’s denosumab biosimilars are being developed and manufactured by mAbxience, with Amneal pursuing regulatory approval and having exclusive US commercialisation rights.  In May 2024, Dr Reddy’s and Alvotech entered into a licence and supply agreement for the commercialisation of AVT03, under which Alvotech develops and manufactures the product and Dr Reddy’s will commercialise it exclusively in the US, and semi-exclusively in the EU and UK.

The filing of the two new complaints means Amgen currently has four US proceedings pending regarding denosumab biosimilars, including lawsuits against Hikma/Gedeon Richter and Shanghai Henlius/Organon, commenced on 25 June 2025.  Amgen has settled a further six US proceedings relating to denosumab biosimilars with:

• Sandoz: proceedings commenced in May 2023, were resolved in April 2024, with Sandoz launching its denosumab biosimilars, Jubbonti® and Wyost®, in June 2025;
• Fresenius Kabi: proceedings commenced in October 2024 were resolved by a global settlement, resulting in the launch of Fresenius’ Conexxence® and Bomyntra® in early July 2025;
• Celltrion: US proceedings settled in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025;
• Accord and Intas: US litigation with Amgen settled in July 2025, permitting launch of Accord/Intas’ denosumab biosimilar from 1 October 2025;
• Samsung Bioepis settled in early September 2025, with the terms of that settlement, including launch dates for Samsung Bioepis’ denosumab biosimilars, remaining confidential; and
• Biocon: US proceedings commenced on 30 June 2025 were settled shortly thereafter, permitting Biocon’s 1 October 2025 launch of Bosaya™ and Aukelso™.

On 4 November 2025, Sandoz and Evotec SE announced they have signed an agreement for Sandoz’s acquisition of 100% of Just-Evotec Biologics EU SAS (including its Toulouse manufacturing site), together with an indefinite technology licence to Evotec’s continuous manufacturing platform technology (J.POD).  The transaction follows a non-binding term sheet signed by the companies in July 2025 relating to the potential acquisition.

Under the agreement, Sandoz will pay an upfront cash consideration of approximately USD 350 million.  Sandoz will also pay additional upfront licence fees for Just Evotec’s continuous manufacturing technology for an indefinite number of molecules, up to 10 of which are royalty bearing.  According to the companies, additional licence fees and development revenues, including success-based milestones, may add up to more than US 300 million over “the coming years”.

The transaction is expected to close in 2025, subject to meeting customary closing conditions, including foreign direct investment clearance by the French authorities.  Upon closing, Just-Evotec Biologics employees will become part of Sandoz.

Sandoz and Just-Evotec have partnered in relation to the development and manufacturing of biosimilars since May 2023.  That partnership was expanded in July 2024, with Sandoz securing long-term commercial supply access to Just-Evotec’s biosimilar manufacturing facility in Toulouse.

On 4 November 2025, Xbrane Biopharma announced that the first patient has been enrolled in the clinical trial of Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab).  The trial is sponsored by Intas, which entered into a global licence agreement with Xbrane for Xdivane™ in November 2024.  Xbrane previously reported that the FDA and EMA had both supported a streamlined combined Phase I and III trial.

Xdivane™ is one of several nivolumab biosimilar candidates lining up to compete with BMS’ Opdivo®.  Others include Amgen’s ABP 206, Reliance Life Science’s RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.  In August 2025, Sandoz wound down its Phase III trial of JPB898 as a measure to streamline its biosimilar nivolumab development program following feedback from regulatory authorities regarding requirements for biosimilar approvals.

On 3 November 2025, Outlook Therapeutics announced that it has re-submitted its Biologics Licence Application (BLA) to the US FDA for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.

The resubmission follows the company’s Type A meeting with the FDA in September 2025 to address the Complete Response Letter (CRL) issued in August 2025.  Outlook Therapeutics “believe[s] this resubmission will resolve the outstanding issue highlighted” in the August 2025 CRL.

Outlook had already resubmitted its BLA to the FDA in February 2025, following receipt of a first CRL from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding further clinical trials.  A second CRL (August 2025) recommended Outlook submit additional efficacy data to support its application for ONS-5010.

Lytenava™ received marketing authorisation in the EU in May 2024 and was launched in the UK and Germany for wet AMD in June 2025.  The Scottish Medicines Consortium also accepted Lytenava™ for use within NHS Scotland in June 2025.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.