Roche drops Herceptin patent in India, opens door to biosimilars

roche herceptin biosimilar (http://www.flickr.com/photos/tawheedmanzoor/2309847575/)

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.”

YOU MIGHT BE INTERESTED IN: The Top 3 Companies Set to Dominate US Biosimilar Market

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.

What do you think? Why not join our discussion on LinkedIn, or leave a comment below. Want more from Total BioPharma? Sign up to our newsletter – it doesn't cost anything and only takes a minute.

If you're interested in hearing more about strategy and innovation in biosimilars, you might be interested in attending the World Biosimilar Congress Europe 2013, 12-13 November 2013.

Leave a Reply

Your email address will not be published. Required fields are marked *