FDAnews Drug Daily Bulletin

Generic Breast Cancer Drug to Make Debut in India

Jan. 21, 2014

Biocon and Mylan announced a joint venture to sell their breast cancer drug CANMAb in India, beginning next month.

“Breast cancer is the most prevalent cancer among Indian women, ahead of cervical cancer and CANMAb will offer a high-quality, more affordable option to breast cancer patients in India,” said Kiran Mazumdar-Shaw, chairperson and managing director at Biocon.

Patent woes have plagued the Indian pharmaceutical market recently, and members of the Senate Finance Committee and the House Ways and Means Committee have called for the U.S. International Trade Commission to investigate Indian policies that it believes restrict trade and violate IP rights.

According to Biocon, the drug will be priced 25 percent below the leading market biosimilar, Roche’s Herceptin, at US $316 for 150 mg and $933 for 440 mg of the treatment.

In August, Roche announced it would not pursue its expired Indian patent on Herceptin (trastuzumab), opening up the product to competition in the country. — Nick Otto

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