Biocon Ltd has received approval from the Drug Controller General of India (DCGI) for sale of a biological clone of Herceptin, the world's best-selling breast cancer drug.
The biosimilar, Trastuzumab, will be 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 release on Tuesday.
Biocon expects to start marketing the drug in India by the fourth quarter of the current financial year.
Swiss drug maker Roche Holding AG, which originally developed Herceptin, relinquished its Indian patent on the drug three months ago.
Roche, however, continues to market the drug worldwide, including in India, under the brand name Herceptin.
''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 in its release.
''This is a major milestone for both partners as Trastuzumab is the world's first biosimilar to be accorded regulatory approval,'' the statement quoted Biocon chairman and managing director Kiran Mazumdar Shaw as saying.
''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.
Trastuzumab is used for the treatment of metastatic breast cancer.
Although, biosimilars are biological copycats of patented drugs, such versions are not called generics because they are not an identical copy.
Roche is reported to have relinquished patent for Herceptin as part of a new strategy for the high-value biological drug in the local market.
Roche had also dropped plans to patent new variants of Herceptin in India and instead decided to partner local drugmaker Emcure Pharmaceuticals Ltd for manufacturing this drug in India and making its 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. But the high cost of biologics in cancer treatment makes 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 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.