Trastuzumab is a monoclonal antibody used in the treatment of metastatic breast cancer. Biocon, which jointly developed CANMab with American pharmaceutical company Mylan, on Tuesday announced that the drug has received marketing authorisation from the Drugs Controller General of India (DCGI). The development is significant for Biocon with Trastuzumab's sales in India estimated at around $21 million in 2012 and around $ 6.4 billion globally in 2012.
This is a major milestone for both partners as it is the worlds first biosimilar Trastuzumab to be accorded regulatory approval. We plan to make CANMAb available to Indian patients in Q4 FY14, said Kiran Mazumdar-Shaw, chairperson & managing director, Biocon. The Indian approval is an encouraging milepost as we plan to leverage this data to support regulatory filings in several countries across the globe.
Over 1,00,000 women are diagnosed with breast cancer every year in India, and Biocon said its new drug will offer an alternative affordable option to patients.
The meticulous development of this important cancer drug has involved extensive product characterisation and clinical trials to demonstrate comparability and similarity in PK (pharmacokinetic), safety, efficacy and immunogenicity against the innovator product, said Mazumdar-Shaw. We are committed to affordable cancer care and believe that biosimilar Trastuzumab will expand patient access to this life-saving drug.