Roche drops Herceptin patent in India, opens door to biosimilars

roche herceptin biosimilar (

Roche has decided not to pursue a patent for Herceptin (trastuzumab) in India, following the dismissal of certain patent applications made by Roche to the Indian patent office last month. 

“Roche has come to the conclusion not to pursue Indian Patent No. 205534 (the secondary patent) and the related divisional applications,” said a Roche spokesperson, according to Bloomberg. “This decision takes into account the strength of the particular rights and the IP (intellectual property) environment in India in general.”

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While Roche's decision to drop the patent on Herceptin might open the door to biosimilar trastuzumab in India, it has to be noted that there are currently no approved biosimilar versions of trastuzumab in the country. Earlier this year, Celltrion, one of the big players in the biosimilar space, announced that it has filed its biosimilar trastuzumab CT-P6 for approval with the Korean Ministry of Food and Drug Safety (MFDS). Meanwhile, Pfizer presented some robust data for their biosimilar trastuzumab in a Phase I trial of PF-05280014.

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