Biotechnology major Biocon today said it has received approval from the Indian drug regulator to market its biosimilar trastuzumab developed jointly with Mylan for treating breast cancer.
"The company has received market authorisation from the Drug Controller General of India (DCGI) for its biosimilar trastuzumab being developed jointly with Mylan for the treatment of Her 2+ metastatic breast cancer," Biocon said in a statement.
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 & 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 milepost as we plan to leverage this data to support regulatory filings in several countries across the globe."
The global sales for trastuzumab stood at USD 6.4 billion in 2012, while in India it recorded sales of USD 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 USD 22 billion by 2020, Biocon said.
The patent expiry of these products in regulated markets is expected from 2015 onwards, it added.
In a statement at the global drug major Mylan's web site the company said it intends to market it's trastuzumab product under the trade name 'Hertraz'.
Mylan has exclusive commercialisation rights for biosimilar trastuzumab in the U S, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries and co-exclusive commercialisation rights with Biocon for product in India.
Commenting on the development, Mylan CEO Heather Bresch said: "This regulatory achievement marks another Mylan first and underscores our commitment to, and confidence in, our biologic development program with Biocon and our belief that these products will become a global growth driver for Mylan over the long-term."