Indian regulator clears Biocon, Mylan's biosimilar of Roche's Herceptin

Biocon announced Tuesday that the Drugs Controller General of India approved its biosimilar version of Roche's Herceptin (trastuzumab) for the treatment of HER2-positive metastatic breast cancer, noting that the drug is "the world's first biosimilar version of Herceptin to be brought to the market." The biosimilar will be marketed under the name CANMAb by Biocon and as Hertraz by co-development partner Mylan.

The launch of the product follows a decision by Roche earlier this year to not pursue reinstatement of its patent for Herceptin in India as part of a new strategy after a patent for the drug lapsed as Roche failed to comply with local regulations following a post-grant challenge. In 2012, Roche entered into a collaboration with Emcure Pharmaceuticals that permitted the latter to locally manufacture and market Herceptin in India to help increase access to the medicine in the country and make it more affordable.

"The Indian approval is an encouraging milepost as we plan to leverage this data to support regulatory filings in several countries across the globe," said Biocon managing director Kiran Mazumdar Shaw, adding "we plan to make CANMAb available to Indian patients in Q4 FY14." As part of the companies' partnership, Mylan holds exclusive commercialisation rights to the biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand and in the EU and European Free Trade Association countries, while the drugmakers hold co-exclusive commercialisation rights in India. Mylan indicated that it expects to launch the biosimilar in India early next year.

Herceptin generated approximately $6.4 billion in revenue in 2012, including $21 million in sales in India.

For related analysis, read ViewPoints: Biosimilar Herceptin approved in India, but regulatory requirements someway below bar set by Europe.

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