Medicosnext
Yet again there has been a clash between global pharmaceutical giant Roche and Indian drug maker Zydus Lifesciences. Roche has filed a complaint against Zydus regarding alleged critical gaps in the clinical trials of its biologic drug Perjeta, a widely-used breast cancer treatment. This isn’t the first time these two companies have found themselves in a legal battle; a similar dispute arose in 2016 over the approval and launch of breast cancer drug Vivitra by Zydus Cadila.
Roche’s primary contention revolves around the procurement of the drug used in the initial phase of clinical trials by Zydus. The Swiss biotech company claims that the drug was not obtained directly from them, raising concerns about its quality and authenticity. Roche suggests the possibility that the drug used by Zydus might be of “questionable quality,” “compromised,” or even “spurious.”
Zydus, based in Ahmedabad, vehemently denies these allegations, viewing them as an attempt to tarnish its reputation and undermine its efforts to make expensive drugs accessible at affordable prices in the Indian market. The company’s spokesperson clarified that Zydus had procured 480 vials of the original innovator reference product (Perjeta) directly from Roche Pharma India in January 2023, and the trial vials in 2022 were not purchased from Roche. The clinical trial, according to the Clinical Trials Registry of India (CTRI), commenced in September 2022.
