World's 1st biosimilar drug for breast cancer

Bengaluru: Bangalore-based bio-pharmaceutical company Biocon on Saturday launched the world’s first biosimilar (developed in an organism) Trastuzumab injection for the treatment of breast cancer here. This is the first drug developed by Biocon in partnership with US-based generic drug maker Mylan. The new drug, CANMAb, will be used to treat HER2-positive advanced breast cancer.

Kiran Mazumdar-Shaw, chairperson and managing director, Biocon, said the company would also launch the injection in other emerging markets. The CANMab injection will compete with Roche’s Herceptin. Herceptin’s global sales were $6.4 billion in 2012 and Indian $21 million.

The drug has been jointly developed out of five molecules with Mylan, since a partnership was signed in 2009. Mylan will also launch CANMab under a different brand in India.

The injection is available in 150mg and 440mg doses at Rs 19,500 and Rs 57,500, respectively. The 440mg dose costs a fourth less than competing drugs, Mazumdar-Shaw said.

Biocon has set up a factory in Bangalore to make the new injection for itself as well as Mylan. Mylan will source its requirements from Biocon for both Indian and developed markets, a senior company official said.

Biocon entered into partnership with Mylan for joint development of a series of drugs for the treatment of various cancers in 2009. At present, four other drugs are under development, of which will begin clinical trials later this year, said Abhijit Barve, president (research and development), Biocon.

Mazumdar-Shaw said breast cancer was the most prevalent cancer among Indians and CANMAb would offer a cheaper option. About 150,000 new patients are diagnosed with breast cancer every year in India, of which nearly a fourth of the cases are HER2-positive and eligible for treatment with CANMAb. Lack of cheap treatment has limited the extent of HER2 testing and it is believed that the proportion of HER2-positive patients is probably higher, she said.

“Biocon intends to make a significant difference in the treatment paradigm for HER2-positive breast cancer in India by enhancing access to more affordable treatment with CANMAb, which offers the same level of safety and efficacy as the reference product. The launch of CANMAb in India is an important milestone for our biosimilars programme and demonstrates our ability to deliver on our promise of affordable innovation with a high quality, world- class product,” the Biocon chief said.

Biocon aims to capture about 15 per cent of the market for anti-breast cancer drugs in India in a year. The market is estimated at Rs 130 crore a year, set to double in 2014.

JOINT EFFORT
CANMAb, developed jointly by Biocon & Mylan, to treat advanced breast cancer
Competing drug Roche’s Herceptin (pictured) global sales $6.4 billion in 2012 and Indian $21 million
Mylan to launch CANMab under a different brand in India
The injection in 150mg and 440mg doses to come for Rs 19,500 and Rs 57,500, respectively
Biocon’s factory in Bangalore to make the new injection for itself as well as Mylan