Zydus Lifesciences has encountered a significant legal challenge in the U.S. related to its development of a cancer biosimilar. A U.S. district court has ruled in favour of the original patent holder, Amgen, over intellectual property rights tied to a key oncology treatment. The ruling may delay Zydus’s entry into the U.S. market with its biosimilar version of the blockbuster drug, which had been seen as a strategic move to capture share in the competitive oncology space.

The legal dispute centres on patent claims surrounding the reference biologic, and the court determined that Zydus infringed on at least one of those claims. This decision could push back launch timelines and potentially affect revenue projections in the near term. While Zydus may consider appealing the verdict or negotiating a settlement, the setback highlights the broader challenges biosimilar manufacturers face in penetrating regulated markets like the U.S.

The case also underscores ongoing patent litigation risks in the biosimilars industry, where innovator companies often aggressively defend their intellectual property portfolios. Despite this legal obstacle, Zydus continues to invest in biosimilar development, having several other assets in the pipeline targeting global markets.

The outcome serves as a reminder that while biosimilars offer significant cost and accessibility benefits, their path to market is often fraught with legal complexities that can disrupt business strategy.