On 17 November 2025, Sandoz announced the US launch of Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab).  Tyruko® is the only natalizumab biosimilar approved (August 2023) and launched in the US and is available for all reference indications.

Tyruko® was developed by Polpharma Biologics pursuant to a global commercialisation agreement with Sandoz reached in 2019.  As part of the agreement, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

Tyruko® was approved in Europe (September 2023) and Australia (April 2025) and was recommended for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) under the same circumstances as Biogen’s Tysabri® in April 2025.

At its November 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two biosimilars:

• Enzene/Theramex’s Osqay®, biosimilar to Amgen’s Prolia® (denosumab). Enzene and Theramex entered into an agreement in 2021 under which Enzene will supply Theramex with its denosumab biosimilar for commercialisation in Europe, the UK, Switzerland and Australia; and
• Gan & Lee Pharmaceuticals’ Ondibta®, biosimilar to Sanofi’s Lantus® (insulin glargine).

There are a number of denosumab biosimilars already 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), Accord Healthcare’s Jubereq® and Osvyrti® (May 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).

The EMA’s CHMP adopted positive opinions in September 2025 for STADA/Alvotech’s Kefdensis® and Zvogra® (AVT03, MAA accepted October 2024), Dr Reddy’s Acvybra® and Xbonzy®, Teva’s Ponlimsi™ and Degevma™ (TVB-009P, MAA accepted October 2024), and Intas’ Denosumab Intas.

Insulin glargine biosimilars have been approved in Europe since 2014 (the first was Eli Lilly’s Abasaglar®).

On 13 November 2025, the FDA announced that it has approved Shanghai Henlius’ Poherdy™ (formerly HLX11, pertuzumab-dpzb) as an interchangeable biosimilar to Roche’s Perjeta®, including in combination with trastuzumab.  Henlius’ Poherdy™ is the first pertuzumab biosimilar approved in the US.

In August 2025, Roche and its subsidiary Genentech sued Henlius in ongoing proceedings in the US District Court for New Jersey alleging infringement of patents relating to Perjeta®.  The proceeding also names as a defendant Henlius’ licence partner, Organon.  Henlius and Organon struck a licensing deal in June 2022 giving Organon exclusive global commercialisation rights to Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”.

A day before the FDA announced approval of Poherdy™, Sandoz and EirGenix entered into a global licensing agreement for EirGenix’s pertuzumab biosimilar, giving Sandoz exclusive commercialisation rights worldwide, excluding certain countries in Asia.

On 13 November 2025, Outlook Therapeutics announced that the US FDA has accepted its Biologics License Application (BLA) for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™ for wet AMD.

The acceptance follows the resubmission of the BLA earlier this month after the company’s Type A meeting with the FDA in September 2025 to address the Complete Response Letter (CRL) issued in August 2025.  According to Outlook, the FDA has advised that it considers the BLA resubmission a complete, Class 1 response to the August 2025 action letter, which results in a 60-day review period from the date of resubmission.  As a result, the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of 31 December 2025.

Outlook had previously 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.

On 12 November 2025, Sandoz and EirGenix announced a global licensing agreement for the commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab).  Under the agreement, Sandoz will have exclusive worldwide commercial rights to the biosimilar, excluding certain countries in Asia, while EirGenix will be responsible for development, manufacturing and supply.

EG1206A has completed its pharmacokinetic clinical study and last month received positive feedback from both the FDA and the European Medicines Agency, confirming that the product qualifies for an abbreviated development pathway allowing for the waiver of Phase III comparative efficacy trials.

Sandoz and EirGenix previously signed a global commercialisation agreement for EG12014, biosimilar to Roche/Genentech’s Herceptin® (trastuzumab), which was approved by the European Commission in November 2023 and is currently under review by the FDA.

Roche has recently indicated that biosimilar competition to Perjeta® is a bigger concern than it previously anticipated.  Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.

On 12 November 2025, Shanghai Henlius announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorisation applications (MAAs) for two denosumab injections: 60mg (Bildyos®; biosimilar to Amgen’s Prolia®) and 120mg (Bilprevda®; biosimilar to Amgen’s Xgeva®).

Just five days earlier, Boan Biotech announced that its MAAs for denosumab biosimilars, BA6101 (60mg, referencing Prolia®) and BA1102 (120mg, referencing Xgeva®), were also accepted by the MHRA.

There are a number of 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).

The EMA’s CHMP adopted positive opinions in September 2025 for STADA/Alvotech’s Kefdensis® and Zvogra® (AVT03, MAA accepted October 2024), Dr Reddy’s Acvybra® and Xbonzy®, Teva’s Ponlimsi™ and Degevma™ (TVB-009P, MAA accepted October 2024), and Intas’ Denosumab Intas.

On 11 November 2025, Viet Nam News, reported that the Vietnam Ministry of Health has granted marketing authorisation for Pembroria™, biosimilar to MSD’s Keytruda® (pembrolizumab), in Vietnam for a three-year period.

Pembroria™ is reportedly manufactured in Russia by a Russian company, Limited Liability “PK-137”.  However, the product was developed by Biocad, which initiated phase 1 clinical trials for the biosimilar (then known as BCD-201) in 2022.

On 31 October 2025, Biocad announced that BCD-201 demonstrated a favourable safety and efficacy profile in real-world clinical trials in Cuba in patients with metastatic and inoperable melanoma.  Biocad claims to have been supplying anticancer drugs such as pembrolizumab to Cuba free of charge since 2023.

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

On 11 November 2025, Johnson & Johnson announced that the Scottish Medicines Consortium (SMC) has accepted Tremfya® (guselkumab) for use in NHS Scotland for adult patients with moderately to severely active Crohn’s disease and ulcerative colitis (UC), who have had an inadequate response, lost response, or were intolerant to either conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.

This follows the recommendation of the National Institute for Health and Care Excellence (NICE) in August 2025 for use within the UK’s NHS.

Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease (IV and SC) and UC (IV) in May 2025, and has been approved for the same indications in the EU (Crohn’s (IV and SC), May 2025; UC (IV), April 2025).  In October 2025, the European Commission approved a SC dosage regimen for UC.

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 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.

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 10 November 2025, Bio-Thera announced that it has entered into an exclusive commercialisation and licence agreement with Dr Reddy’s in relation to BAT2306, biosimilar to Novartis’ Cosentyx® (secukinumab).  Under the agreement, Bio-Thera will have responsibility for developing, manufacturing and supplying BAT2306, while Dr Reddy’s will be responsible for regulatory approvals and commercialisation in Southeast Asian countries, including Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Thailand and Vietnam.

Bio-Thera completed a phase 3 clinical trial of BAT2306 in plaque psoriasis in 2024, and a phase 1 trial in 2023.  Secukinumab biosimilars are also under development by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis, status unknown).

Bio-Thera & Dr Reddy’s have previously partnered on biosimilars in SE Asia.  In March 2025, Bio-Thera and Dr Reddy’s announced exclusive commercialisation agreements for BAT2206 and BAT2306, biosimilars to J&J/Janssen’s Stelara® (ustekinumab) and Simponi® (golimumab), respectively, in SE Asia.