Mylan&Biocon receive first Indian biosimilar approval for trastuzumab

November 26, 2013 1:30 PM

Mylan Inc. yesterday announced that its partner Biocon has received approval for a Mylan-Biocon trastuzumab product from the Drug Controller General of India.

This is the first regulatory approval for a Mylan-Biocon developed biosimilar product. The product is a biosimilar to Roche’s Herceptin, indicated for the treatment of HER2 overexpressing breast cancer. Mylan intends to market its trastuzumab product under the trade name Hertraz.

Mylan CEO Heather Bresch commented, “This regulatory achievement marks another Mylan first and underscores our commitment to, and confidence in, our biologic development program with Biocon and our belief that these products will become a global growth driver for Mylan over the long-term. We expect to launch our trastuzumab product in India early next year, marking our first launch of a biologic, and we look forward to bringing a high quality, affordable product to patients in India who need it. This launch also further strengthens our expanding commercial presence in India, as we enter the oncology and critical care segments.”

Trastuzumab is one of the five biologic products Mylan is developing in partnership with Biocon for the global marketplace. Mylan has exclusive commercialization rights for biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries and co-exclusive commercialization rights with Biocon for product in India. Mylan expects to launch trastuzumab in India early in 2014.

According to IPSOS, trastuzumab had sales in India of approximately $21 million for the 12 months ended Dec. 31, 2012.


Source: Mylan press release

1 Comment

  • Muhamamd Tahir Aziz

    Good to hear
    I would like to know that what criteria is being used for the approval of Biosimilar?
    Is Mylan Trastuzumab is a declared Biosimilar per eu standard?

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