Archive · 13 Jan 2026
Delhi High Court Allows Zydus to Sell Nivolumab Biosimilar
The Delhi High Court has allowed Zydus Lifesciences to sell its version of a cancer drug called nivolumab.
This drug is a biosimilar, which means it is similar to an existing drug but made by a different company.
The original drug is made by E.R. Squibb & Sons LLC and is sold under the brand name Opdivo.
The court said Zydus can sell its version because the original drug's patent is about to expire, and it's important for people who need this life-saving medicine.
Zydus has to keep detailed records of its sales so that the original company can be compensated if they win a patent dispute later.
The drug is used to treat several types of cancer, and it's important in India where cancer rates are rising.
Delhi High Court allows Zydus Lifesciences to sell its biosimilar version of nivolumab, an anti-cancer drug.
The court modified a previous injunction that had restrained the launch, citing public interest and the nearing expiry of Squibb’s patent.
Zydus must maintain detailed sales records and file periodic audited statements until the patent expires on 2 May 2026.
Nivolumab is a monoclonal antibody immunotherapy used to treat several cancers, including lung and head and neck cancers.
The dispute began when Squibb alleged Zydus was preparing to launch a biosimilar before the patent expiry, while Zydus argued its product did not infringe the patent.
- Who
- Zydus Lifesciences and E.R. Squibb & Sons LLC
- What
- Delhi High Court allows Zydus to sell its biosimilar version of nivolumab
- When
- The decision was made on Monday (specific date not mentioned)
- Where
- Delhi High Court, India
- Why
- The court cited public interest and the nearing expiry of Squibb’s patent
- Drug
- Nivolumab (biosimilar)
- Companies Involved
- Zydus Lifesciences, E.R. Squibb & Sons LLC
- Court
- Delhi High Court
- Patent Expiry
- 2 May 2026
- Drug Type
- Monoclonal antibody immunotherapy
- Conditions
- Zydus must maintain sales records and file periodic audited statements
- Significance
- Life-saving cancer drug with rising incidence in India