An order prohibiting Zydus Lifesciences from marketing Sigrima, a biosimilar to Roche's Pertuzumab (brand name Perjeta), a medication for breast cancer, has been issued by the Delhi High Court. The Swiss pharmaceutical giant Roche launched a patent infringement lawsuit against Zydus and Dr. Reddy's Laboratories, and the court responded with its ruling.
Zydus Lifescience's shares dropped more than 3% from intraday highs after opening at a 52-week high of ₹1,203 a share. At this hour, the shares of Dr. Reddy's Laboratories were down 0.27%.
The manufacturer of oncology drugs requested an injunction, claiming that Sigrima and Womab, the co-marketed version created in association with Dr. Reddy's, violated its patents. As Zydus launched the biosimilar in spite of pending lawsuits and unresolved regulatory issues, the legal fight grew more intense.
The manufacturer of cancer medications requested an injunction, claiming that Sigrima and Womab, the co-marketed version created with Dr. Reddy's, violated its patents. Zydus's decision to commercialize the biosimilar in spite of pending litigation and regulatory concerns escalated the legal fight.
According to the Court, Zydus released the product on June 27, 2024, after receiving "conditional" permission from the National Institute of Biologicals on April 4, 2024. The corporation neglected to reveal these changes throughout the legal procedures, even though this action took place while the lawsuit was still pending.
Judge Sanjeev Narula, who is overseeing the case, expressed concerns regarding Zydus's product launch schedule. "The timing of the product's launch suggests a strategic move by the defendant to establish a market presence before any potential judicial restrictions could be imposed."
Roche's legal representative said in many hearings held in February and April that Zydus' biosimilar was still pending regulatory approval. The attorney questioned Zydus' production processes' transparency as well as the current state of the company's regulatory applications. The petitioners pleaded with the court to hold off on Zydus releasing Sigrima onto the market until all legal and regulatory matters were settled beyond any reasonable doubt.
(Input from various sources)
(Rehash/Priyanka Pandey/MSM)