On 1 March 2026, Australia’s Pharmaceutical Benefits Scheme published its summary of changes.  Among the changes is the expansion of the PBS listing for nivolumab and ipilimumab to enable broader access for the treatment of advanced or metastatic cancers.

The Australian Pharmaceutical Benefits Advisory Committee (PBAC) had recommended a broad, multi-indication PBS listing for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) in advanced or metastatic cancers in September 2025.  The multi-indication PBS-listing of nivolumab and ipilimumab takes effect from 1 March 2026 and is the first of its kind in Australia.

The PBS listing allows clinicians to apply clinical judgment and discretion in using the medicines according to the best available evidence at the time, including for rare cancers for which regulatory submissions are unlikely.  The listing also removes the once in a lifetime limitation for these medicines when used for advanced or metastatic cancers.

On 24 February 2026, Ono Pharmaceutical announced that the Korean Ministry of Food and Drug Safety has granted additional approval of Opdivo® (nivolumab) intravenous infusion in combination with Yervoy® (ipilimumab), for the treatment of adults with unresectable or metastatic microsatellite instability-high (MSI-High) or mismatch repair deficient (dMMR) colorectal cancer (CRC).  This combination was previously approved in Korea for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (July 2025).

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 combination of Opdivo® and Yervoy® has also been approved for colorectal cancer in EU (December 2024), US (April 2025), Australia (June 2025), Canada (August 2025) and Taiwan (January 2026).

Zydus Lifesciences recently successfully opposed BMS’s final appeal in seeking a preliminary injunction in India against Zydus’ nivolumab biosimilar, Tishtha®, the first nivolumab biosimilar in the world to reach market.  At least Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius, Enzene, Reliance Life Sciences and Biocon have nivolumab biosimilars on the market or 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 11 February 2026, the Supreme Court of India dismissed the Special Leave Petition of BMS requesting an appeal from the decision of the High Court of Delhi appellate division that allowed Zydus to launch its low cost nivolumab biosimilar, Tishtha®, pending resolution of the infringement claim brought by BMS.  The Supreme Court has also ordered Zydus to provide a sample of its product to BMS for mapping against its patent claims.

Zydus launched Tishtha® in India on 22 January 2026, just over a week after the first instance 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’ Court loss will be encouraging to 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.

In an effort to “champion equitable access to medicine” Brazil and India have entered into a series of agreements to support Brazilian domestic manufacture of publicly funded oncology medicines.

On 21 February 2026, it was announced at the India-Brazil Business Forum in New Delhi that Brazil and India have entered into three “Productive Development Partnerships” (PDPs) to “leverage state purchasing power” and domestically manufacture “crucial” oncology medicines.  Under the agreements, various oncological drugs, including biosimilars nivolumab and pertuzumab, will be produced in Brazil.  The agreements involve Brazilian public institutions and private companies, including Indian companies, and foresee technology transfer and local production.  The Brazilian Ministry of Health said that it estimates its investment will be up to US$140 million in the first year, potentially reaching US$ 1.9 billion over 10 years.

Brazilian manufacture is intended to reduce costs associated with importing complex biological compounds and to secure a steady and reliable supply that is less susceptible to international market fluctuations or logistical challenges.

Brazilian state-owned Bahiafarma will be involved in the production of both biosimilars.  The nivolumab project will also involve Brazilian company Bionovis, and India’s Dr Reddy’s Laboratories.  Pertuzumab will be produced with Bionovis and Biocon Biologics do Brasil.

In an addendum to the PDPs, Brazil and India have agreed to 5 years of further joint initiatives addressing vaccines and APIs across an array of health challenges (oncology, diabetes, cardiovascular disease, and disease prevention) with a focus on “bio-manufacturing, biologics, health digitization, telemedicine solutions, and the application of artificial intelligence in healthcare.”

Biocon and Lupin have signed technology transfer agreements with Brazil’s public health research institute Fiocruz.

Dr Reddy’s has a nivolumab biosimilar under development, while Biocon Biologics has a pertuzumab biosimilar in its pipeline.

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.