Zydus barred from selling cancer biosimilar, for now

The Delhi High Court has issued an interim injunction, restraining Zydus Lifesciences from selling its breast cancer drug Sigrima - a biosimilar version of Roche's Perjeta (pertuzumab) - in a patent infringement case filed by the Swiss pharma company.

Roche had sought injunctive reliefs against the sale and distribution of Sigrima and Womab of Dr Reddy's, arguing that they infringe its patents numbered IN 268632 and IN 464646.

Dr Reddy's in June entered into a licensing agreement with Zydus to co-market the biosimilar under brand name Womab.


Zydus told court that its pertuzumab biosimilar has been given "conditional" approval on April 4, 2024, and the permission to market was granted by the National Institute of Biologicals on June 27, 2024. The court took objection to launching the drug even as the litigation is underway and rapped Zydus for not providing "timely updates" about significant regulatory developments.

"The timing of the product's launch suggests a strategic move by the defendant (Zydus) to establish a market presence before any potential judicial restrictions could be imposed," Justice Sanjeev Narula said in his order issued on Tuesday.

"Allowing the defendant to continue the sale and distribution of the impugned product could alter the market situation, which would significantly disadvantage the plaintiffs (Roche), especially if the product is later found to infringe upon the plaintiffs' patents," the order said. "An injunction serves as a preventive measure to avoid the market from being flooded with the infringing product, thus protecting the plaintiffs' interests while the substantive issues are conclusively resolved."

Roche's counsel, during the court hearings on February 23, April 4, April 24 and May 13, argued that the biosimilar in question was still pending regulatory approval, and there was a lack of transparency about the processes employed by Zydus in manufacturing their biologic, as well as the status of their application for regulatory approvals.

Roche's counsel had requested the court to direct Zydus not to launch their product in the market. A Zydus spokesperson declined to comment, citing that the matter is sub-judice. A Dr Reddy's spokesperson, too, declined to comment.

Pertuzumab is a critical treatment for HER2 positive breast cancer patients. Zydus Research Centre's team developed its biosimilar in house.