Zydus Lifesciences has moved the Division Bench of the Delhi High Court to appeal against a recent interim order that restrained the company from manufacturing or selling its biosimilar version of Nivolumab, a cancer immunotherapy drug originally marketed as Opdyta by Bristol-Myers Squibb.

The single-judge order, issued on July 18, 2025, prohibits Zydus from manufacturing, selling, advertising, importing, or exporting its Nivolumab biosimilar until the final outcome of the case or the expiry of the suit patent on May 2, 2026.

The injunction stems from a patent infringement suit filed by Bristol-Myers Squibb and E.R. Squibb, who claim Zydus was preparing to commercially launch its biosimilar, coded ZRC-3276, based on clinical trial activity and other indications. Zydus received a legal notice in May 2022, and a lawsuit was filed in 2024 citing concerns over patent violation.

Zydus has contested the allegations, arguing that its product does not infringe the patent, citing differences in molecular binding and manufacturing processes. It also invoked the Bolar exemption under Section 107A of the Indian Patents Act, stating that its clinical trial activities are protected and do not amount to infringement.

The next hearing is scheduled for August 8, 2025. Zydus has also filed a post-grant opposition to the patent, which is still pending. The outcome of this case could have broader implications for the Indian biosimilars market, particularly around patent enforcement and access to affordable biologics.