Mumbai: Sigrima, Zydus Lifesciences’ biosimilar challenge to Roche’s breast cancer blockbuster brand Perjeta is swirling into controversies. After a recent injunction against its launch from the Delhi High Court on charges of concealing key regulatory milestones from the court. Roche had sued Zydus for infringement of its formulation patents on Perjeta.
Besides the disputes brought on in the court, Roche’s spokesperson has indicated that the drug’s manufacturing and launch timelines need a closer examination of Zydus’ biosimilar.
Roche spokesperson notes that in the case of a biologic (or a biosimilar), it takes about six to eight months for drug substance (or API) to be manufactured and then about two months for the drug product to be made (including QC clearance, packaging). Media reports have alleged that the Indian drug maker created false invoices for supplies of the drug to Kenya. But upon receiving the approvals from the Indian regulatory authority, it subsequently routed its supplies to the Indian market.
Earlier media reports indicated that on April 19, 2023, Zydus had secured a large supply deal with Ripple Pharma of Nairobi for the supply of 60000 vials of the pertuzumab 420 mg biosimilar drug. Based on that order, Zydus requested for an export grant from the Indian regulatory agency. The approval for exports to Kenya was granted on April 28, 2023.
Read more: Interim Injunction on Zydus’s biosimilar Sigrima: Roche’s Commercial Motivation?
However, ET Pharma sought views from a leading industry expert who said there are no apparent violations if a drug meant for export is sold in the Indian market. Given that the approval from the Central Drugs Standard Control Organisation (CDSCO) was received in April 2024 and a subsequent market launch was made in June 2024, Roche’s contention seems baseless.
The expert explained drug substance manufacturing takes around 40 days and drug product takes another 20 days including the batch release. Good manufacturing practices (GMP) manufacturing of drug substance starts from clinical supply. Hence, GMP batches are available for the National Institute of Biologicals (NIB) testing. “Commercialisation requires an additional licence. A firm can apply for commercial manufacturing of unapproved product for export,” he noted.
The veteran added the entire process from manufacturing the drug substance to the final drug product involves strict adherence to GMP standards, rigorous quality control, and necessary regulatory approvals to ensure the safety and efficacy of the pharmaceutical products.
Zydus has not responded to requests for clarification since it said the case is sub judice.
Experts noted that Roche’s moves seem motivated against the launch of a biosimilar drug as it will face a tough rival in the market. Zydus had signed a marketing pact with Dr. Reddy’s for Sigrima. Market experts said Perjeta costs Rs 47.6 lakh for a year’s supply while Zydus’s biosimilar will cost around Rs 13.5 lakh annually.
Also, Roche has high stakes in the African continent and may attempt to block Zydus from making a dent in that market. Media reports show Roche is conducting about 61 clinical trials in Africa of which two-thirds are in the oncology segment.
