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.

On 14 January 2026, Sandoz announced that the European Commission has approved Ondibta® (insulin glargine solution for injection in pre-filled pen), biosimilar to Sanofi’s Lantus® Solostar®.  Ondibta® is registered in Europe by Gan & Lee Pharmaceuticals and received a positive recommendation from the EMA’s CHMP in November 2025.

Sandoz expects to launch Ondibta® in Europe by early 2027.  The product is approved for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

Sandoz and Gan & Lee partnered in December 2018 in relation to the commercialisation of insulin glargine, insulin lispro and insulin aspart biosimilars.  Under the agreement, Sandoz is responsible for commercialising the products in Europe and other key territories, while Gan & Lee has responsibility for development, registration, manufacturing and supply.

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

At the J.P. Morgan Healthcare Conference on 14 January 2026, Samsung Epis Holdings announced the addition of six biosimilar candidates to Samsung Bioepis’ pipeline: dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab.

The announcement confirms the November 2025 report that Samsung Bioepis had commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan), with the biosimilar in the early development stage in preparation for preclinical trials.  The same report had also indicated that Samsung Bioepis is developing biosimilars to Regeneron/Sanofi’s Dupixent® (dupilumab), Janssen’s Tremfya® (guselkumab) and Eli Lilly’s Talz® (ixekizumab).

Samsung Bioepis has launched 11 biosimilars to 10 INNs on market around the world and has a biosimilar to MSD’s Keytruda® (pembrolizumab), (SB27) in phase 1 and 3 clinical trials (commenced April 2024).  The company is aiming to have 20 biosimilars in its portfolio by 2030.

At the J.P. Morgan Conference, Samsung Epis also announced that the FDA has approved Samsung Bioepis’ investigational new drug application (IND) for SBE303, an antibody-drug conjugate, which is expected to enter a Phase 1 first-in-human clinical trial in patients with advanced refractory solid tumours this year.

There are a number of companies with dupilumab biosimilars under development.  In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.  In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.  Alvotech and Advanz entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries.

Biosimilar development of guselkumab is also 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.

Biosimilars to Takeda’s Entyvio® (vedolizumab) are in development by at least Alvotech (Phase 3 clinical trial for AVT16 commenced September 2024), Intas Pharmaceuticals (approval from India’s CDSCO for a Phase 1 bioequivalence study of INTP53 obtained in February 2025) and Polpharma Biologics (which entered into licensing agreements with Fresenius Kabi and MS Pharma for commercialisation of PB016 in August and September 2025).

Ocrelizumab biosimilars (referencing Roche’s Ocrevus®) are in clinical trials sponsored by Biocad (Phase III, enrolment commenced November 2025), Sandoz (comparative pharmacokinetic trial underway), Amgen (Phase III trial reported in January 2025) and Celltrion (Phase III IND for CT-P53 partially approved by the EMA in August 2023).

On 14 January 2026, Korea Biomedical Review reported that Korean-headquartered Chong Kun Dang has received approval from the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its phase 1 clinical trial protocol for CKD-706, biosimilar to Regeneron/Sanofi’s Dupixent® (dupilumab).

According to the report, Chong Kun Dang intends to conduct a European-based clinical trial to demonstrate pharmacokinetic equivalence between CKD-706 and Dupixent® in healthy adults, as well as to assess pharmacodynamics, safety and immunogenicity.

There are a number of dupilumab biosimilars under development.  Alvotech and Advanz Pharma entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of dupilumab (among other biosimilars), in Europe and other regions.

In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America.  In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.

As reported in November 2025, and confirmed at the J.P. Morgan Health Conference in January 2026, Samsung Bioepis is developing a dupilumab biosimilar.  It was also reported in December 2025 that Russia’s Binnopharm Group and China’s Mabwell signed a MOU in relation to localising the production of Mabwell’s dupilumab biosimilar in Russia and the EAEU.

On 13 January 2026, Celltrion revealed at the 44^th Annual J.P. Morgan Healthcare Conference that it plans to commercialise up to 18 biosimilar products by 2030 and 41 products by 2038.  This is a slight reduction of its plans announced in September 2024 to have a “portfolio of 22 [biosimilar] products by 2030”.

Celltrion currently has 11 biosimilars approved in various jurisdictions, namely adalimumab, aflibercept, bevacizumab, denosumab, infliximab/SC infliximab, omalizumab, rituximab, tocilizumab, trastuzumab, and ustekinumab.

Celltrion also unveiled at the J.P. Morgan Healthcare Conference that it plans to submit up to 16 investigational new drug (IND) applications by 2028, including up to 10 antibody-drug conjugates (ADCs), 4 multi-specific antibodies (msAbs), 1 recombinant protein and 1 peptide.  Three Celltrion IND applications for ADCs (CT-P70, CT-P71 and CT-P73) were accepted by the FDA in 2025.

On 6 January 2026, Celltrion officially opened its first US manufacturing facility, which it acquired from Eli Lilly in late 2025.  Under the deal, Celltrion will conduct contract manufacturing operations for Eli Lilly valued at 678.7 billion won (US$470.5 million) over a 3-4 year period.  According to Celltrion, the acquisition will “ensure long-term supply chain resilience” by eliminating tariff and trade risks and strengthening its competitiveness in the US market.

On 13 January 2026, Shanghai Henlius Biotech announced that its Biologics Licence Application (BLA) for HLX04, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) has been accepted for review by the FDA.

HLX04 has previously been approved in China (2021) and in multiple Latin American countries, including Bolivia, the Dominican Republic, and Mexico.  In October 2020, Henlius entered into a co-development and exclusive licensing agreement with Hong Kong-headquartered EssexBio, under which EssexBio was granted an exclusive licence to develop, manufacture and commercialise HLX04 globally.

The first bevacizumab biosimilar approved in the US was Amgen’s Mvasi® in September 2017.  There are currently five other bevacizumab biosimilars included in the FDA’s approved drugs database: Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 2022), Celltrion’s Vegzelma™ (September 2022), Bio-Thera/Sandoz’s Avzivi® (December 2023), and Biocon Biologics’ Jobevne™ (April 2025).

Henlius also has an ophthalmic preparation based on HLX04 under development, which is intended for the treatment of wet AMD.  In August 2025, a new drug application for Henlius’ ophthalmic bevacizumab biosimilar, HLX04-O, was accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration.

On 12 January 2026, an appellate Division of the High Court of Delhi issued its judgment overturning the grant of a preliminary injunction awarded to Bristol Myers Squibb (BMS) in July 2025, restraining Zydus’ Indian launch of nivolumab ZRC-3276, biosimilar to BMS’ Opdivo®.

The proceedings were brought by BMS, alleging that ZRC-3276 infringes its Indian patent IN340060, titled “Human Monoclonal Antibodies to Programmed Death 1 (PD-1) for use in treating Cancer”.  The relevant independent claim of IN340060 includes a functional protein-binding affinity limitation as well as specifying an amino acid sequence.  The two appeal judges found that the first instance judge was wrong to find that ZRC-3276 was likely to have an infringing amino acid sequence merely because it was a biosimilar to nivolumab when there was no evidence of the actual sequence of ZRC-3276.  The appeal court noted that biosimilarity is assessed based on comparable safety, efficacy and quality, not amino acid sequence, separating the regulatory issues from issues of patent infringement.

The Appeal Court accepted that there was evidence that neither ZRC-3276 nor Opdivo® satisfied the protein-binding affinity limitation of the claims, further weakening the infringement case based on a product-to-product comparison.

Given the weakened infringement case, and the fact IN340060 will expire in just over 4 months, the Appeal Court held that the public interest in the availability of lower-cost, life-saving drugs tipped matters in favour of the injunction being overturned.  However, Zydus was ordered to provide an account of profits for sales of the allegedly infringing product until expiry of the patent in suit.

Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024.

Nivolumab biosimilars aimed at the Indian market are also under development by Enzene and Reliance Life Sciences.  At least Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius and Biocon also have nivolumab biosimilars under development.

On 12 January 2026, Ono Pharmaceutical announced that the Taiwan Food and Drug Administration has approved a new indication for Opdivo® (nivolumab) intravenous infusion in combination with Yervoy® (ipilimumab), for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-High) or mismatch repair deficient (dMMR) colorectal cancer (CRC).   This combination was previously approved in Taiwan in July 2025 for the first-line treatment of unresectable or metastatic hepatocellular carcinoma.

In 2011, Ono granted BMS commercialisation rights for Opdivo® excluding in Japan, South Korea and Taiwan, where Ono retains all rights.  In July 2014, Ono and BMS agreed to expand their collaboration agreement to jointly develop and commercialise multiple immunotherapies as single agent and combination regimens for cancer in Japan, South Korea and Taiwan.

The Opdivo®/Yervoy® combination has also been approved for the same indication in EU (December 2024), US (April 2025), Australia (June 2025) and Canada (August 2025).

At least Zydus Lifesciences, Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius, Enzene, Reliance Life Sciences and Biocon have nivolumab biosimilars in development.  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.