Other Updates

On 5 February 2026, Korea Biomedical Review reported that Korean headquartered HK inno.N has received approval from Korea’s Ministry of Food and Drug Safety for Izambia Prefilled Syringe and Denbrayce Injection, biosimilars to Amgen’s Prolia® and Xgeva® respectively.

HK inno.N entered an exclusive licence agreement with mAbxience in January 2023 for the commercialisation of the denosumab biosimilars.  mAbxience’s Izamby® and Denbrayce® received European approval in July 2025.

Celltrion’s Stoboclo® and Osenvelt® were the first denosumab biosimilars to be approved in Korea (November 2024).  In March 2025, Daewoong Pharmaceutical launched Celltrion’s Stoboclo® in Korea at a 28% discount to reference product Prolia®.  Celltrion entered into a joint sales agreement with Daewoong in October 2024, under which the two companies jointly promote Celltrion’s denosumab biosimilars in Korea.  Boryung launched Samsung Bioepis’ Xbryk® on 1 August 2025, following its regulatory approval in May 2025.  Samsung Bioepis and Hanmi Pharmaceuticals announced their joint South Korean launch of Samsung Bioepis’ Obodence™ (reference: Prolia®) in July 2025.

On 5 February 2026, CVS Health announced that pharmacy benefits manager, CVS Caremark, will begin offering Samsung Bioepis’ Ospomyv® and Celltrion’s Stoboclo®, biosimilars to Amgen’s Prolia® (denosumab), on major US national commercial template formularies from 1 April 2026.

According to CVS, this is aimed at helping to expand the adoption of lower-cost biosimilar medications, and builds on its exclusion of AbbVie’s Humira® (adalimumab) from its formulary in favour of adalimumab biosimilars priced at a discount, including Sandoz’s Hyrimoz®.

Samsung Bioepis’ Ospomyv® was the second Prolia® biosimilar approved in the US (in February 2025).  BPCIA litigation commenced by Amgen alleging that Samsung Bioepis’ denosumab biosimilars infringed 36 US patents relating to denosumab was settled in September 2025.

Amgen and Celltrion settled their BPCIA litigation regarding denosumab in January 2025, with Celltrion launching Stoboclo® in July 2025 (following FDA approval in March 2025).  Celltrion’s second denosumab biosimilar, Osenvelt®, biosimilar to Amgen’s Xgeva®, was previously included on the CVS Caremark formulary.

On 5 February 2026, Alvotech announced positive results from a pharmacokinetic study for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab).

The Phase 1 study evaluated the comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Entyvio® in 385 healthy adults.  The trial met all the primary endpoints and demonstrated the pharmacokinetic similarity for both the subcutaneous and intravenous routes of administration of the vedolizumab biosimilar when compared with Entyvio®.  Alvotech is planning  regulatory submissions based on the results of the study.

Alvotech is currently developing two biosimilars to Entyvio®, AVT16 for intravenous administration, and AVT80 for subcutaneous administration.  Alvotech commenced a Phase 3 clinical trial for AVT16 in September 2024 in moderate to severe ulcerative colitis.

Other vedolizumab biosimilars in development include Intas’ INTP53 (approval to conduct Phase I bioequivalence study received in February 2025) and Polpharma Biologics’ PB016 (licensing agreement with MS Pharma signed in September 2025 for MENA region).  In January 2026, Samsung Bioepis announced that it has added a vedolizumab biosimilar to its pipeline.

On 4 February 2026, Mexican-headquartered Saya Biologics announced that it has entered a strategic collaboration agreement with Kashiv BioSciences for commercialisation of an undisclosed supportive biosimilar oncology therapy in Mexico and the Central America and Caribbean (CAC) region, covering 11 countries.

Under the agreement, Kashiv BioSciences will manufacture and supply the biosimilar to Saya Biologics, whilst Saya Biologics will be responsible for regulatory registration, commercialisation, and distribution across the region.  According to the announcement, Saya has already submitted a regulatory dossier for the biosimilar to local authorities.

Kashiv has recently entered into a number of commercialisation agreements in relation to its omalizumab biosimilar, ADL-018.  On 11 August 2025, Kashiv announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for ADL-018, for the Latin American Market.  Kashiv had previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

On 4 February 2026, R-Pharm announced it has obtained Russian marketing authorisation for the anti-cancer drug Arcetux™, biosimilar to Eli Lilly/Merck KgGa’s Erbitux® (cetuximab).  This is the first biosimilar cetuximab to be approved in Russia.

Arcetux™ has been approved for two indications, local head and neck cancer treatment and metastatic colorectal cancer.  Cetuximab is listed on the Russian Vital and Essential Drugs (VED) list, which allows for increased accessibility for patients.

The approval follows R-Pharm’s announcement in December 2025 at the 29th Russian Oncology Congress that Arcetux™ had completed Phase III trials.

Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched globally, having been approved in India in January 2023 and launched in May 2023.  Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™.  Sincere Pharmaceutical/Mabpharm’s Enlituo® (cetuximab beta) was approved in China in June 2024.

On 3 February 2026, Amgen announced its financial results for Q4/2025 and full year 2025, including providing the following update on its biosimilar pipeline:

• Nivolumab: Amgen has completed enrolment in a comparative clinical study comparing ABP 206 (nivolumab) with the reference product, BMS’ Opdivo®, in patients with early-stage non-squamous NSCLC as adjuvant treatment. According to the US clinicaltrials.gov database, Amgen completed a Phase 3 study to compare the pharmacokinetic similarity of ABP 206 with Opdivo® in patients with resected advanced melanoma in October 2025.

• Ocrelizumab: A pharmacokinetic similarity/comparative clinical study of ABP 692 compared to Genentech/Roche’s Ocrevus® is enrolling patients with relapsing-remitting multiple sclerosis.  Amgen announced this Phase 3 study at the JP Morgan Annual Healthcare conference on 13 January 2025.

• Pembrolizumab: Two clinical trials are underway. Amgen completed enrolment in a combined pharmacokinetic/comparative clinical study of ABP 234 (pembrolizumab) with MSD’s Keytruda® in patients with advanced or metastatic non-squamous NSCLC (initiated May 2024) and is currently enrolling patients in a pharmacokinetic similarity study comparing ABP 234 with Keytruda® in patients with early-stage non-squamous NSCLC as adjuvant treatment.

Amgen reported that its biosimilars segment delivered US $3 billion in 2025 sales, an increase of 37% year-over-year, with particularly strong performance from Pavblu®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), which reached US $700 million in full year sales.  Pavblu® was the first aflibercept biosimilar launched in the US in October 2024 and remains the only aflibercept biosimilar on the US market to date (following settlements, launches of Biocon’s, Formycon/Klinge’s, Sandoz’s, Celltrion’s and Alvotech/Teva’s aflibercept biosimilars are planned in the second half of 2026).  At the same time, Amgen acknowledged that biosimilars are applying competitive pressure in relation to sales of Prolia® and Xgeva® (denosumab).

Nivolumab, pembrolizumab and ocrelizumab biosimilars have been developed, or are in development, by a number of other companies:

• Nivolumab: In January 2026, Zydus was the first to market its nivolumab biosimilar, Tishtha®, in India.  Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius, Enzene, Reliance Life Sciences and Biocon all have nivolumab biosimilars in their pipelines.

• Ocrelizumab biosimilars are in clinical trials sponsored by Biocad (Phase III, enrolment commenced November 2025), Sandoz (comparative pharmacokinetic trial underway), and Celltrion (Phase III IND for CT-P53 partially approved by the EMA in August 2023). Samsung Bioepis announced in January 2026 that it had added an ocrelizumab biosimilar to its pipeline.

• Pembrolizumab: In August 2025, Bioéticos launched the first pembrolizumab biosimilar in Paraguay under the name Pembrolizumab Bioéticos. In November 2025, Biocad’s Pembroria™ (pembrolizumab) was approved in Vietnam.  A number of other pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, 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®.  In December 2025, Formycon announced agreements with MS Pharma for the commercialisation of pembrolizumab biosimilar FYB206 in the MENA region and with Zydus Lifesciences for the US and Canada.

On 2 February 2026, Alvotech announced that it has entered into supply and commercialisation agreements with Sandoz for multiple unidentified biosimilars for Australia, New Zealand and Canada.

In Australia and New Zealand, the agreement covers three biosimilars across immunology and gastroenterology, whilst the agreement in Canada covers an ophthalmology biosimilar supplied as a prefilled syringe for intravitreal injection.

Under the agreements, Sandoz will lead the regulatory submissions, commercialisation and distribution in the relevant jurisdictions, and Alvotech retains responsibility for development, manufacture and supply of the products to Sandoz.

Alvotech has a number of ophthalmology and immunology/gastroenterology biosimilars in its pipeline.  In relation to ophthalmology, Alvotech has received approval for AVT06 (Mynzepli® (aflibercept), 2mg) in the EU, UK and Japan (Sandoz has its own aflibercept 2mg biosimilar (Afqlir®/Enzeevu®) which has been approved in a number of jurisdictions).  Alvotech is also developing AVT29, a biosimilar to Regeneron/Bayer’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.  In the immunology and gastroenterology fields, Alvotech has received approval for AVT05 (golimumab) in Japan, the UK and the EU and is developing AVT16 (vedolizumab), AVT10 (certolizumab pegol), AVT28 (ixekizumab), AVT48 (canakinumab), AVT41 (guselkumab), AVT65 (ofatumumab), and AVT19 (dupilumab).

On 2 February 2026, R-Pharm announced that the Russian Ministry of Health has approved Persinthia™, biosimilar to Genentech/Roche’s Perjeta® (pertuzumab), for the treatment of HER2-positive breast cancer.  The approval follows R-Pharm’s announcement in December 2025 at the 29th Russian Oncology Congress that Persinthia™ had completed Phase III trials.

Persinthia™ is the second pertuzumab biosimilar approved in Russia, following approval of Pertuvia™ in May 2025 by OOO-PK-137, a subsidiary of Biocad.

Shanghai Henlius/Organon’s Poherdy®/HLX11 (pertuzumab) was approved in the US in November 2025.  In January 2026, Henlius, Organon, Genentech and Roche settled BPCIA litigation in relation to the biosimilar.

Sandoz and EirGenix have a commercialisation deal in place for pertuzumab biosimilar EG1206A (November 2025) and 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.

In India, Enzene’s pertuzumab biosimilar was launched in September 2025 and is being marketed by Enzene’s parent company, Alkem Laboratories, as Pertuza®, and Hetero Healthcare as Perzea®.  Zydus’ Sigrima™ was approved in India in September 2024, but is subject to ongoing litigation.  Intas received approval for its pertuzumab biosimilar in December 2024, subject to submission of further studies.

On 2 February 2026, Sandoz announced that it has launched Enzeevu®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg, in Canada.  Enzeevu® was approved by Health Canada in October 2025 for all Eylea® indications.

Other aflibercept biosimilars approved in Canada include Biocon’s Yesafili® (June 2025, launched July 2025 following a settlement with Regeneron/Bayer), Amgen’s Pavblu® (July 2025), Apotex’s Aflivu™ (July 2025), Samsung Bioepis’ Opuviz® (October 2025), Celltrion’s Eydenzelt® (November 2025), and Formycon/Klinge/Valorum Biologics’ Ahzantive™ (November 2025).

On 1 February 2026, Sandoz’s Afqlir®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg, was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in vial and pre-filled syringe presentations for all reference indications.  Afqlir® is Australia’s first aflibercept biosimilar to be PBS-listed.

Afqlir® was approved by the Therapeutic Goods Administration (TGA) on 27 May 2025, together with Sandoz’s second biosimilar aflibercept brand, Enzeevu®.  While both Afqlir® and Enzeevu® were considered and recommended for listing on the PBS in August 2025, only Afqlir® was PBS-listed.

In June 2025, Regeneron and Bayer commenced patent infringement proceedings against Sandoz asserting Regeneron’s AU2012205599 relating to methods of treatment for angiogenic eye disorders.  Sandoz cross-claimed for invalidity.  An application by Regeneron/Bayer for a preliminary injunction preventing the Australian launch of Afqlir® was refused by the Federal Court of Australia in September 2025.  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.

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.  Regeneron and Bayer have cross-claimed for infringement.  These proceedings remain pending with a hearing listed in March 2027.

Celltrion’s Eydenzelt® was the first aflibercept biosimilar approved in Australia in March 2025 (solely for myopic CNV).  It was recommended for PBS listing in December 2025.  Samsung Bioepis’ Opuviz® (aflibercept) received TGA approval in September 2025.