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.

On 22 January 2026, Daiichi Sankyo announced that Enhertu® (trastuzumab deruxtecan) has been approved by China’s National Medical Products Administration (NMPA) as the first and only HER2-directed antibody-drug conjugate for the second line treatment of adults with HER2 positive metastatic gastric or gastroesophageal junction cancer who have received one prior trastuzumab based regimen.  This is the sixth indication approved for Enhertu® in China.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights.  Daiichi Sankyo is solely responsible for manufacturing and supply.

Samsung Epis recently announced that Samsung Bioepis is adding a trastuzumab deruxtecan biosimilar to its pipeline, with the biosimilar in the early development stage in preparation for preclinical trials.

The Ontario government has reported that it is fast-tracking funding for a number of cancer drugs including the combination of BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) for treatment of both colorectal and liver cancers.

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.

Ipilimumab biosimilars are also on their way, with Sandoz and Shanghai Henlius Biotech announcing a global collaboration agreement for an ipilimumab biosimilar in April 2025.

Zydus has wasted no time in announcing the launch of its nivolumab biosimilar, Tishtha™, on 22 January 2026, following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.

Zydus’ nivolumab biosimilar, previously referred to as ZRC-3276, received regulatory approval in India in July 2024.  It is the first nivolumab biosimilar in the world to reach the market and is priced at about one quarter the cost of the reference product, BMS’ Opdivo® (sold in India as Opdyta®).

Competing nivolumab biosimilars are under development for the Indian market by Enzene and Reliance Life Sciences.  Globally, Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius and Biocon also have nivolumab biosimilars under development.

On 22 January 2026, Zhitong Finance reported that AstraZeneca’s Imfinzi® (durvalumab) was approved by China’s National Medical Products Administration (NMPA) for use, in combination with carboplatin and paclitaxel, as a first-line treatment for adult patients with mismatch repair-deficient (dMMR) primary advanced or recurrent endometrial cancer, followed by maintenance therapy with durvalumab alone.

Imfinzi® has been approved for this indication in other jurisdictions, including the US (June 2024), the EU (August 2024) and Australia (where it is listed on the PBS as of August 2025).

To date, there have been no announcements of any therapeutic durvalumab biosimilars in development.

In its Q3/FY26 earnings call on 21 January 2026, Dr Reddy’s announced that its abatacept biosimilar, referencing BMS’ Orencia®, is expected to be approved in the US at the end of 2026 in IV form and in early 2028 in a subcutaneous formulation, with launches soon after those dates.  In Europe, Dr Reddy’s is aiming to simultaneously launch both IV and SC abatacept after expected approval in July 2027.

According to pipeline information on Dr Reddy’s website, its abatacept biosimilar has completed phase 1 clinical trials and phase 3 trials are underway.

In March 2023, Dr Reddy’s entered an exclusive worldwide agreement with Coya Therapeutics under which Coya is licensed to use Dr Reddy’s abatacept biosimilar to develop and commercialise a subcutaneous combination product, COYA 302 (abatacept with COYA-301, Coya’s low-dose interleukin-2 (IL-2)).

An abatacept biosimilar is also being developed by Kashiv Biosciences, which announced the successful completion of a phase 1 clinical trial of KSHB002 (abatacept) in January 2025.

On 19 January 2026, Hikma announced the US launch of Enoby™ and Xtrenbo™ (denosumab-gbde), biosimilars to Amgen’s Prolia® and Xgeva® respectively.

Enoby™ and Xtrenbo™ were approved by the FDA in September 2025.  The biosimilars were developed and are manufactured by Gedeon Richter.  Under a December 2021 licence and commercialisation agreement, Hikma is responsible for FDA registration and has exclusive rights to commercialise the biosimilars in the US.

In June 2025, Amgen commenced BPCIA litigation against Gedeon Richter and Hikma alleging infringement of 32 US patents relating to denosumab.  That litigation was settled in November 2025, with the terms of the settlement providing that Richter/Hikma’s denosumab biosimilars could not be launched in the US before at least 1 January 2026.

A number of denosumab biosimilars have been approved and launched in the US.  This includes Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), Accord’s Osvyrti® and Jubereq® (approved November 2025, not yet launched), and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

On 16 January 2026, Bayer announced that the European Commission has approved Eylea™ 8mg  (aflibercept 8mg, 114.3 mg/ml solution for injection) for macular oedema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion.  This is the third indication approved in Europe for Eylea™ 8mg.

The EU approval follows a positive opinion of the EMA’s CHMP for the new indication in December 2025.  Eylea™ 8mg was first approved in the EU in January 2024 for the treatment of nAMD and diabetic macular oedema.

Eylea™ 8mg (known as Eylea HD® in the US) was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2mg and 8mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Eylea HD® was FDA approved for the RVO indication in November 2025, following US vial approval for nAMD, DME and diabetic retinopathy in August 2023.  Eylea™ 8mg is also approved for nAMD and DME (as intravitreal injection) in multiple other countries, including Japan (January 2024), UK (January 2024) and Australia (June 2024).  Eylea™ 8mg pre-filled syringe (OcuClick) was approved in Europe (September 2024), Australia (October 2024) and Korea (August 2025).  Regeneron/Bayer have submitted marketing authorisation applications for Eylea™ 8mg for the treatment of patients with macular oedema following RVO including in Japan (May 2025).

Alvotech is 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.

On 15 January 2026, Zydus Lifesciences Ltd and Agenus Inc. announced the closing of a deal in which Zydus acquired Agenus’ biologics manufacturing facilities in Emeryville and Berkeley, California, and obtained exclusive rights to develop and commercialise Agenus’ botensilimab and balstilimab (BOT+BAL) immunotherapy combination program in India and Sri Lanka.

The transaction includes a US$75 million cash payment by Zydus to Agenus for the transfer of the biologics manufacturing facilities, a US$16 million purchase of shares in Agenus by Zydus and up to US$50 million in milestone payments by Zydus to Agenus based on BOT+BAL production orders.  Agenus is also eligible to receive a 5% royalty on net sales of BOT+BAL in India and Sri Lanka.

Zydus is establishing a new US subsidiary, Zylidac Bio LLC, which will provide biologics manufacturing sites offering CDMO services to biopharmaceutical companies globally.  According to Zydus, the launch of Zylidac Bio is designed to provide a “safe-harbour” for global biopharmaceutical companies seeking to transition their supply chains to US based partners, in light of the US BIOSECURE Act, which was signed into law in December 2025 and restricts US federal procurement and grants involving biotechnology products or services provided by “biotechnology companies of concern”.

Zydus recently signalled its entry into the North American market, entering into an exclusive licensing and supply agreement with Formycon for the commercialisation of Formycon’s FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in the US and Canada.

On 14 January 2026, Samsung Bioepis announced that Korea’s Ministry of Food and Drug Safety has approved a pre-filled pen formulation (PFP) of Epyztek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  According to Samsung Bioepis, this is the first PFP presentation of ustekinumab to be approved in Korea.

Epyztek® (SB17) was the first ustekinumab biosimilar approved in South Korea in April 2024.  SB17 was approved in Europe in April 2024 as Pyzchiva® and a Pyzchiva® autoinjector was launched in May 2025 as the first commercially available biosimilar ustekinumab pre-filled pen in Europe.  In the US, Pyzchiva® was approved in July 2024 and launched in February 2025, in PFS and vial forms.  Under a development and commercialisation agreement with Sandoz entered in September 2023, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.

The EMA’s CHMP adopted a positive opinion for Celltrion’s PFP/autoinjector presentation of its ustekinumab biosimilars, Steqeyma® and Qoyvolma®, in December 2025.  Celltrion’s PFP presentation of the product was approved in Australia in the same month.