Biocon's Transtuzumab receives marketing authorization in India

Biocon today announced that it has received marketing authorization for its biosimilar 'Trastuzumab' from Drugs Controller General of India (DCGI), jointly developed with Mylan, for the treatment of HER2-positive metastatic breast cancer.


A joint collaboration between Biocon and Mylan

Trastuzumab will be marketed in India under the brand name of CANMAb by Biocon, and is expected to be available to Indian patients in Q4 FY14.

Trastuzumab is also the world's first biosimilar version of 'Herceptin' to be brought to the market.
Every year, over 100,000 new breast cancer patients are diagnosed with this disease. The cost of biologics in cancer treatment is extremely high which makes access unaffordable to a large patient pool.

Speaking on the occasion, Ms Kiran Mazumdar Shaw, CMD, Biocon, said, "This is a major milestone for both partners as it is the world's first biosimilar to be accorded regulatory approval. We plan to make CANMAb available to Indian patients in Q4 FY14."

Ms Shaw further added, "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. We are committed to affordable cancer care and believe that Trastuzumab will expand patient access to this life saving drug. The Indian approval is an encouraging milepost as we plan to leverage this data to support regulatory filings in several countries across the globe."

Trastuzumab is expected to offer an alternative affordable option, thereby enhancing access to treatment for cancer patients in India and the world over said the press release on Tuesday.

The global sales for Trastuzumab stood at US$ 6.4 billion in 2012, while in India it recorded sales of approximately US$ 21 million.


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