Other Updates

On 30 January 2026, Celltrion announced that it has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in major European countries, including Germany, France and Spain.

Celltrion’s launch strategy in France has involved winning bids from private hospital groups by prioritising supply stability.  According to Celltrion, this has resulted in securing 80% of the French private tocilizumab market (by volume).  In Spain, Celltrion secured Avtozma® contracts in regional public tenders held in the Basque Country, Madrid, and Andalucia and it was selected as the supplier by a Ministry of Health bidding agency, INGESA, for 8 regions.  Celltrion is also leveraging its sales of existing products, such as Remsima SC® (infliximab) and Yuflyma® (adalimumab), to expand prescriptions to tocilizumab in European retail markets.

Avtozma® was the third tocilizumab biosimilar approved in the EU, in February 2025, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence® in June 2024.

Avtozma® was launched in the US in an IV formulation in October 2025, following its US approval in January 2025.  It had previously been launched in Korea in June 2025.  The biosimilar has also been granted marketing authorisation in a number of other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025), Japan (September 2022) and New Zealand (December 2025).

At its December 2025 Intracycle Meeting (the outcomes of which were published on 30 January 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended a broad, multi-indication PBS listing of MSD’s Keytruda® (pembrolizumab) for the treatment of advanced or metastatic cancers.

The recommendation comes after MSD received a knock-back from PBAC for the multi-indication (broad) listing for Keytruda® in July 2025.  At that time, in a decision MSD described as “bewildering”, PBAC had considered that because the proposed funding model “was restricted to the indications for which pembrolizumab was registered with the Therapeutic Goods Administration” it “would not provide access to some patient groups in which there is a significant unmet clinical need, such as rare cancers.”  In reporting the outcomes of the December 2025 meeting, the PBAC noted that MSD has now “largely addressed its concerns from the July 2025 submission”.

The PBAC recommendation for Keytruda® follows a similar recommendation, made at PBAC’s September 2025 meeting, for a broad, multi-indication listing for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) in advanced or metastatic cancers.

The PBAC has recommended that pembrolizumab join the Risk Sharing Arrangement (RSA) that it had previously recommended for the nivolumab/ipilimumab broad listing (if that proceeds to listing), given that there are several indications where both pembrolizumab and nivolumab (± ipilimumab) would be treatment options in the same or similar population.  The PBAC has asked the Department of Health to review each of the recommended broad listings after three years to ensure the use remained consistent with its intention.

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 30 January 2026, Samsung Bioepis announced that it has secured a settlement and licence agreement with Regeneron and Bayer for the commercialisation of SB15, biosimilar to Eylea® (aflibercept, 2 mg), in countries excluding the US and Canada.  The announcement comes a day after Alvotech announced a similar settlement with Regeneron/Bayer on the same molecule.

Samsung Bioepis is permitted to launch SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement (excluding Korea where it is already on the market) from May 2026.

SB15 was the third aflibercept biosimilar to be approved in the EU in November 2024 as Opuviz®, and was approved in the UK under the same brand name in April 2025.  The biosimilar received Korean approval (as Afilivu®) in February 2024 and Australian approval (as Opuviz®) in September 2025.

Samsung Bioepis and Regeneron/Bayer have been in litigation regarding aflibercept in multiple countries.  In October 2025, the Hague District Court granted an injunction preventing Samsung Bioepis from launching SB15 in the Netherlands.  In the UK, Samsung Bioepis defeated an injunction application brought by Regeneron/Bayer in October 2025 and in December 2025, Samsung Bioepis successfully overturned a Korean preliminary injunction.

BPCIA litigation in the US remains on foot.  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 affirmed an earlier decision in June 2024 (US District Court -Northern District of West Virginia), 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 January 2026, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended authorisation of BMS’s Opdivo® (nivolumab) in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy.

Opdivo® has been approved in the EU for several other indications including a subcutaneous formulation for various solid tumours; non-small cell lung cancer; melanoma; gastric, gastroesophageal junction, or oesophageal adenocarcinoma; and in combination with Yervoy® for unresectable or advanced hepatocellular carcinoma;  microsatellite instability–high or mismatch repair deficient unresectable or metastatic colorectal cancer.

A number of nivolumab biosimilars are in development, with Zydus recently being first to market its biosimilar, Tishtha®, in India.  Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius, Enzene, Reliance Life Sciences and Biocon have nivolumab biosimilars in their pipelines.

BMS has applied to the Supreme Court of India for leave to appeal against the 12 January 2026 decision of the High Court of Delhi appellate division, which allowed Zydus to launch Tishtha®, biosimilar to BMS’ Opdivo®/Opdyta®, in India pending resolution of the patent infringement claim brought by BMS.  The petition for leave to appeal was listed by the Supreme Court of India on 29 January 2026.  A hearing is scheduled for 4 February 2026.

In overturning a preliminary injunction granted in July 2025 preventing launch of Tishtha®, the High Court appellate division put significant weight on the public interest in having access to lower cost, life-saving drugs and held that BMS’s interests could be preserved by Zydus providing accounts of its sales.  Presumably, if granted leave to appeal, BMS will ask the Supreme Court to revisit this balancing of interests.

Zydus launched Tishtha® in India on 22 January 2026, just over a week after the High Court decision.  The biosimilar had received regulatory approval in India in July 2024 and is the first nivolumab biosimilar in the world to reach the market.  In India, Tishtha® is priced at about one quarter the cost of BMS’ Opdivo®/Opdyta®.

BMS’ appeal will be closely watched by other companies with nivolumab biosimilars in the pipeline aimed at the Indian market, such as  Enzene and Reliance Life Sciences.  Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius and Biocon also have nivolumab biosimilars under development.

On 29 January 2026, Alvotech announced a settlement and licence agreement with Regeneron & Bayer in relation to all remaining patent disputes worldwide (excluding the US) concerning Alvotech’s AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg).  This follows an earlier settlement between the companies, announced in December 2025, in relation to the US launch of AVT06.

Under the settlements, Alvotech and its commercial partners are permitted to launch AVT06:

• from 1 January 2026, in the UK and Canada, and in Japan (excluding the DME indication);
• from 1 May 2026 in the European Economic Area and all other countries in the world (excluding the US);
• from 1 November 2026 in Japan with all approved indications; and
• in Q4/2026 (or earlier under certain undisclosed circumstances) in the US.

AVT06 was approved in the EU and UK (where it is being commercialised as Mynzepli® by Advanz Pharma), in the EU for commercialisation in Germany as Afiveg® by STADA in September 2025, and in Japan (where it is being commercialised as Aflibercept BS by Fuji Pharma) in September 2025.  A Biologics Licence Application for AVT06 was accepted by the FDA for review in February 2025.

In January 2026, the Munich Regional Court granted Regeneron/Bayer a preliminary injunction preventing Alvotech/Advanz Pharma from marketing AVT06 in 21 countries.  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.  These proceedings, including any appeals, are now resolved by the settlement.

On 28 January 2026, Korea Biomedical Review reported that Dong-A ST’s Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), has received marketing approval from Health Canada.

Imuldosa® has already been launched in 19 countries, including the UK and Ireland (April 2025) and the US (August 2025).  It has also obtained marketing approval in the Middle East and North Africa region, including Saudi Arabia, Qatar, and the United Arab Emirates.

Imuldosa® (previously known as DMB-3115) was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma and Dong A-ST acquired the development and commercialisation rights in 2020.  In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals under which Intas received exclusive commercialisation rights to the ustekinumab biosimilar worldwide, excluding Japan, Korea and certain other Asian countries.  Intas is commercialising Imuldosa® through its global affiliates, including Accord BioPharma in the US and Accord Healthcare in Europe, the UK, and Canada.

A number of ustekinumab biosimilars have been approved and launched in Canada to date, including JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Samsung Bioepis’ Pyzchiva™ (approved August 2024), Fresenius’ Otulfi® (approved December 2024, launched May 2025) and Biocon’s Yesintek™ (approved October 2025).

On 26 January 2026, MS Pharma announced that it has entered an exclusive agreement with Hetero Group in relation to the commercialisation in Algeria of 5 undisclosed “established biosimilars” in therapeutic areas including oncology, immunology and haematology.

The biosimilar portfolio is reported to have an estimated total market value of USD 45 million in Algeria (as of 2024).  The agreement will be implemented by MS Pharma’s Algerian affiliate, El Kendi, and Hetero Group’s subsidiary, Hetero Biopharma, and will involve “localisation and technology transfer”.

MS Pharma has entered into a number of agreements for commercialisation of biosimilars in the MENA region over the last year, including with Formycon for biosimilar pembrolizumab (December 2025); Polpharma for biosimilar guselkumab, ocrelizumab and vedolizumab (September 2025); and Kashiv Biosciences for biosimilar omalizumab (August 2025).

On 29 January 2026, Celltrion announced the Canadian approval of its high-dose Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in 300mg pre-filled syringe (PFS) and autoinjector (AI) formulations.  Celltrion now has Canadian approved PFS and AI formulations of Omlyclo® in all strengths of Canadian approved Xolair® (75mg, 150mg and 300mg).

Omlyclo® was the first omalizumab biosimilar approved in Canada in December 2024 and remains the only Canadian approved biosimilar omalizumab to date.

The approval of the high dose formulations of Omlyclo® in Canada follows approvals of a PFS presentation of the 300mg dosage form in the US, in December 2025, and in the EU, in November 2025.

Aurobindo, Teva, Glenmark and Kashiv  also have omalizumab biosimilars under development.   On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market.  Kashiv has 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 and by the European Medicines Agency in October 2025.

On 23 January 2026, Samsung Bioepis published its twelfth US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q1/2026 edition reports that, as of December 2025, the FDA has approved up to 90 biosimilars across 20 unique biosimilar molecules, 63 of which have been launched in the US.  This is an increase over Q4/2025, when there had been 80 US biosimilar approvals and 58 US biosimilar launches.

The biosimilars FDA approved in Q4 2025 were Celltrion’s Eydenzelt® (aflibercept) (approved October 2025, due to launch Q4/2026, referencing Regeneron’s Eylea®), Shanghai Henlius’ Poherdy® (pertuzumab) (approved November 2025, referencing Roche’s Perjeta®), Lupin’s Armlupeg™ (pegfilgrastim) (approved December 2025, referencing Amgen’s Neulasta®), Formycon’s Nufymco® (ranibizumab) (approved December 2025, referencing Genentech’s Lucentis®) and Accord’s Osvyrti®/Jubereq® (approved November 2025) and mAbxience’s Boncresa™/Oziltus™ (approved December 2025), referencing Amgen’s Prolia® and Xgeva® (denosumab) respectively.

The Q4/2025 US biosimilar launches were: Shanghai Henlius/Organon’s Bildyos® & Bilprevda® (denosumab) (October 2025), Celltrion’s Avtozma® (tocilizumab) (October 2025), Bio-Thera/Hikma’s Starjemza™ (ustekinumab) (November 2025) and Polpharma/Sandoz’s Tyruko® (natalizumab) (November 2025).

Samsung Bioepis reports that key highlights from the market analysis include:

• ASPs decreased by 52% (on average) within 5 years of the first biosimilar launch. More mature markets achieve greater price reductions over time (up to 77%).  However, trends in ASPs within specific markets may be affected by “intentional ASP repositioning and the deliberate removal of products from the market”.
• As was the case in Q4/2025, there remains only a single biosimilar competitor to Regeneron’s Eylea® (aflibercept) in the US market (Amgen’s Pavblu®, launched October 2024) offering a WAC discount of -12%. However, there are four approved aflibercept biosimilars, 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).
• In the immunology market, private label brands are common for adalimumab and ustekinumab, but, unlike the case for adalimumab, most ustekinumab biosimilars have not adopted a dual or high WAC strategy.

The report predicts that the evolution from rebate-driven PBM contracts to transparent and fiduciary models may present a “catalyst for widespread adoption” of biosimilars.