Biotechnology major Biocon, on Tuesday, said it had received market authorisation from the Drug Controller General of India (DCGI) for its biosimilar trastuzumab product. The drug, which is being developed jointly with Mylan, is used for the treatment of Her 2+ metastatic breast cancer.
The approval for biosimilar trastuzumab in India is an extremely important milestone for Biocon, as it is the first biosimilar version of Herceptin to be brought to the market, it added.
Trastuzumab is equivalent of Herceptin, a registered brand of drug major Roche.
The biosimilar trastuzumab will be marketed in India under the brand name of CANMAb by the company, and is expected to be available to Indian patients in the fourth quarter of FY14, Biocon said.
Commenting on the development, Biocon Chairperson and Managing Director Kiran Mazumdar Shaw said “This is a major milestone for both partners as it is the world’s first biosimilar trastuzumab to be accorded regulatory approval. The Indian approval is an encouraging mile post as we plan to leverage this data to support regulatory filings in several countries across the globe.”
The global sales for trastuzumab stood at $6.4 billion in 2012, while in India it recorded sales of $21 million, Biocon said.
Biocon and Mylan have been co-developing a portfolio of biosimilar monoclonal antibodies and complex biologics, comprising Trastuzumab, Pegfilgrastim, Bevacizumab, Adalimumab and Etanercept since 2009, it added. In 2013, this partnership was extended to co-development of biosimilar insulin analogs for the global markets. The overall global opportunity for biosimilars is estimated to be $22 billion by 2020, Biocon said.