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 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.

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 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.

On 6 January 2026, Biocon Biologics announced that it will unveil three new biosimilars at the 2026 J.P. Morgan Healthcare Conference to be held 12-16 January 2026 in San Francisco.  The as yet unnamed biosimilars are for pembrolizumab (referencing MSD’s Keytruda®), nivolumab (referencing BMS’ Opdivo®) and trastuzumab/hyaluronidase (referencing Roche’s Herceptin® SC, marketed in the US as Herceptin Hylecta™).  The stage of development of each of the biosimilars is not yet known.

Bioéticos claimed to have launched the first pembrolizumab biosimilar in Paraguay in August 2025 under the name Pembrolizumab Bioéticos.  In November 2025, Biocad’s Pembroria™ (pembrolizumab) was reportedly 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.

There are a number of nivolumab biosimilars already undergoing clinical trials, including Sandoz’s JPB898 (phase I), Amgen’s ABP 206 (phase III), Xbrane/Intas’ Xdivane™ (phase I/III), Boan Biotech’s BA1104 (phase III), and Reliance Life Sciences’ R-TPR-067 (phase I/III).  In December 2025, Shanghai Henlius announced that the FDA approved an IND for a phase I trial of HLX18 (nivolumab).

Celltrion announced in December 2025 that it has been conducting clinical trials for Herzuma® SC (CT-P6 SC), biosimilar to Roche’s Herceptin® SC/Herceptin Hylecta™, since February 2025 and plans to submit applications for approvals of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.

On 19 December 2025, Shanghai Henlius Biotech announced to investors that the US FDA has approved an investigational new drug application (IND) for the phase 1 clinical trial of HLX18, biosimilar to BMS’ Opdivo® (nivolumab), for the treatment of multiple solid tumours.  Henlius proposes to commence the clinical trial in the United States when the conditions are met.

Other nivolumab biosimilars already undergoing clinical trials include Amgen’s ABP 206 (phase III), Xbrane/Intas’ Xdivane™ (phase I/III), Boan Biotech’s BA1104 (phase III), and Reliance Life Sciences’ R-TPR-067 (phase I/III).

In August 2025, Sandoz voluntarily suspended its phase III trial of its nivolumab biosimilar, JPB898, as part of its decision to streamline its clinical trials following “ongoing encouraging and favourable regulatory developments” and feedback from major regulatory authorities regarding the requirements for biosimilar approvals.

Enzene Biosciences sought permission to conduct a phase III trial in India for its nivolumab biosimilar, but was requested to revise its proposed protocol.  Also in India, Zydus obtained approval of its ZRCr-4276 but has been prevented from launching due to legal action by BMS.

On 17 December 2025, Bristol Myers Squibb announced that Canada’s Drug Agency (CDA-AMC) has issued a positive reimbursement recommendation for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) who meet certain criteria.

The combination of Opdivo® plus Yervoy® has been approved for a range of cancer treatments including for:

• Colorectal cancer in Australia, Canada, Europe, Japan, USA; and
• Hepatocellular carcinoma in Canada, Europe, Japan, Korea, Taiwan,

A number of nivolumab biosimilars are under development including Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.  In August 2025, Sandoz wound down its Phase III trial of JPB898 as a measure to streamline its biosimilar nivolumab development program following feedback from regulatory authorities regarding requirements for biosimilar approvals.