Biocon and Mylan's Herceptin biosimilar approved in india

By Dan Stanton

- Last updated on GMT

Related tags Monoclonal antibodies Breast cancer

Biocon and Mylan's Herceptin biosimilar approved in india
The Drug Controller General of India has approved a biosimilar version of Roche’s Herceptin developed by Biocon and Mylan.

“Since 2009, Biocon and Mylan have been co-developing a high value portfolio of biosimilar monoclonal antibodies and complex biologics,”​ a Biocon spokesperson told

“As part of this collaboration, Mylan and Biocon share development, capital and certain other costs to bring products to market.”

Now trastuzumab - a biosimilar of Roche’s breast cancer drug Herceptin - has received its first regulatory approval in India and will be manufactured from Biocon’s Bangalore facility, which the firm says has “India’s largest biologics manufacturing capacity.”

Biocon’s Chair Kiran Mazumdar Shaw added in a statement: “This is a major milestone for both partners as it is the world’s first biosimilar Trastuzumab to be accorded regulatory approval.”

“The meticulous development of this important cancer drug has involved extensive product characterization and clinical trials to demonstrate comparability and similarity in PK (pharmacokinetic), safety, efficacy and immunogenicity against the innovator product.”

For Mylan, this is the first product approved in its biologics portfolio, and the firm will begin to co-market the biosimilar in India early next year. As part of the agreement with Biocon, Mylan has full exclusive commercial rights to the drug in the US, Canada, Japan, Australia, New Zealand and in the EU.

Roche and Herceptin

According to Reuters​, the race to develop a biosimilar to Herceptin opened up in India in August when Roche decided not to pursue a patent application for the mAb.

“This decision takes into account the strength of the particular rights and the IP (intellectual property) environment in India in general,”​ a Roche spokesperson told the publication.

According to Roche’s financial report 2012, Herceptin had global sales of CHF 5.9bn ($6.5bn). Herceptin sales in India for 2012 stood at $21m, Biocon said, but according to Roche’s 2012 financial report, global sales reached CHF 5.9bn ($6.5bn).

Biocon and Mylan are also pursuing bioequivalent versions of Roche’s Avastin, Abbvie’s Humira, Amgen’s Neulasta and Etanercept, and are also being pursued by the two firms, with patent expiration of these products in regulated markets expected from 2015 onwards, the firms said.

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