Delhi HC clears Zydus to sell biosimilar of BMS cancer drug Nivolumab

The Delhi High Court on Monday cleared the way for Zydus Lifesciences to manufacture and sell a biosimilar version of Nivolumab, a blockbuster cancer drug patented by US pharmaceutical major Bristol Myers Squibb (BMS), delivering a significant boost to the Indian drugmaker just months before the patent expires.

A division bench set aside an earlier single-judge order that had temporarily restrained the Ahmedabad-based company from making and selling the biosimilar, ruling that access to affordable treatment could not be denied to patients. “The ailing public cannot be deprived of Zydus’ drug,” the bench observed.

Nivolumab, marketed globally as Opdivo and sold in India under patent protection, is used in the treatment of several cancers. BMS’s Indian patent for the drug is due to expire on May 2, a key factor in the court’s decision. While allowing Zydus to proceed, the bench directed the company to maintain detailed accounts of sales until the patent lapses.

The ruling overturns a July 18 order by Justice Mini Pushkarna, who had restrained Zydus from launching the biosimilar after holding that BMS would suffer irreparable harm if interim relief was not granted.

BMS had argued that Zydus was conducting clinical trials and intended to commercially launch its biosimilar during the life of a valid patent. Zydus strongly disputed the claim, maintaining that its product, ZRC-3276, does not infringe the suit patent and complies with India’s regulatory framework. The company said it had already applied for marketing approval with the country’s drug regulator.

The drugmaker also pointed to prior proceedings, noting that a post-grant challenge filed by its subsidiary had led the Opposition Board to recommend revocation of the patent, strengthening its case.