Biocon, Mylan Get Nod From Indian Drug Regulator To Market Biosimilar Version Of Herceptin Used For Treating Breast Cancer

Biocon Ltd (NSE:BIOCON) on Tuesday announced it has received approval from the Drugs Controller General of India, or DCGI, to sell a biosimilar version of Herceptin, a best-selling breast cancer drug, which the company co-developed with Canonsburg, Pa.-based Mylan Inc (Nasdaq: MYL), in India.

Trastuzumab is used for the treatment of Her 2+ metastatic breast cancer, and its biosimilar will be sold in India under the brand name, Canmab, Biocon said in a statement. Canmab is the first biological equivalent of Herceptin, a breast cancer drug manufactured and marketed by Swiss giant, Roche, in global markets including India, and the Indian regulator’s decision to allow Biocon and Mylan to market the generic version of the blockbuster drug comes three months after Roche’s patent on Herceptin lapsed in India.

“This is a major milestone for both partners as it is the world’s first biosimilar Trastuzumab to be accorded regulatory approval,” Kiran Mazumdar Shaw, Biocon’s chairperson and managing director, said 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.”

Trastuzumab is one of the five biologic products Mylan is jointly developing with Biocon for global markets. Mylan has exclusive commercialization rights for trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union countries, along with co-exclusive marketing rights with Biocon for the product in India.

“We expect to launch our trastuzumab product in India early next year, marking our first launch of a biologic… This launch also further strengthens our expanding commercial presence in India, as we enter the oncology and critical care segments,” Heather Bresch, CEO of Mylan, said in a statement.

Roche had said in August that it did not intend to restore its patent for Herceptin in India, as part of a new global strategy for the marketing of the drug in India. According to a report from Mint, a business newspaper, the Swiss company has partnered with local drug maker, Emcure Pharmaceuticals Ltd, to produce the drug in India with an aim to sell it at a lower price.

A course of Herceptin, which includes 12 shots, reportedly cost about 1.2 million rupees ($19,200) in India. Global sales for Trastuzumab stood at $6.4 billion in 2012, while in India, it recorded sales of $21 million, according to the Biocon statement.

Biocon's shares were trading up 0.69 percent on India's BSE Sensex index in mid-morning trade.