Mumbai: Biocon Ltd said on Tuesday that the Drugs Controller General of India (DCGI) has given it permission to sell a biological copy of Herceptin, the world’s best-selling breast cancer drug.
The biosimilar trastuzumab, a biological copy of Herceptin, was developed jointly by Biocon and US generic drug maker Mylan Inc., and will be sold in India under the brand name Canmab, Biocon said in a statement on Tuesday.
It will be available in India by the fourth quarter of fiscal year 2014.
Trastuzumab, a medicine originally developed and patented by Swiss drug maker Roche Holding AG, is sold by Roche in world markets, including India, under the brand name Herceptin. DCGI’s approval comes three months after Roche relinquished its Indian patent on it.
A biosimilar is equivalent to a copycat version of a biological drug. But such versions are not called generics because they are not an identical copy. Trastuzumab is used for the treatment of metastatic breast cancer.
“The regulatory approval for biosimilar trastuzumab in India is an extremely important milestone for Biocon as it is the world’s first biosimilar version of Herceptin to be brought to the market,” Biocon said on Tuesday.
“This is a major milestone for both partners as it is the world’s first biosimilar Trastuzumab to be accorded regulatory approval,” said Biocon chairman and managing director Kiran Mazumdar-Shaw in a statement.
“The Indian approval is an encouraging milepost as we plan to leverage this data to support regulatory filings in several countries across the globe,” she added.
Roche said in August that its decision to let the Indian patent for trastuzumab lapse was part of a new strategy for the high-value biological drug in the local market. It has no plans to seek a restoration of the patent.
“Regular reviews of our patent portfolio are a routine business practice. In this connection, Roche has come to the conclusion not to pursue the Indian patent for trastuzumab,” Roche India’s director corporate affairs, market access and compliance officer G.K. Raman had said in August.
Mint reported on 14 August that if Roche does not restore the patent in six months through a separate process, generic firms can legally produce the medicine in India.
In July, Roche had also decided not to pursue two of its applications for patenting new variants of Herceptin in India. This followed Roche’s decision to partner with local drug maker Emcure Pharmaceuticals Ltd for producing this drug in India and making it available at a lower price.
Breast cancer is one of the most common cancers in India, with over 100,000 patients diagnosed with it every year. The cost of biologics in cancer treatment is extremely high, which makes access to drugs unaffordable to many patients. The biosimilar is expected to offer an affordable alternative in India and other countries.
The global sales for trastuzumab were $6.4 billion in 2012, while in India it recorded sales of $21 million, according to data available with the industry.
Since 2009, Biocon and Mylan have been co-developing a high value portfolio of biosimilar monoclonal antibodies and complex biologics, comprising five drugs, including trastuzumab.
The global market in biosimilars will be worth $22 billion by 2020, according to industry estimates.
Source: live mint