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Mylan and Biocon apply to FDA for biosimilar approval

Published on 12/01/17 at 10:27am

Mylan, the US-based generics specialist, and Biocon, an Indian biopharmaceutical company, have applied for a biologics license application (BLA) for approval of their biosimilar to breast cancer drug Trastuzumab. If the drug passed through the process, it would make Biocon the first Indian company to have a biosimilar pass through the FDA’s stringent pathway to biosimilar approval.

The drug is a biosimilar to Roche’s Herceptin, a drug that garnered Roche $6.54 billion in global sales in 2015, and a decision from the FDA is expected by 3 September of this year. It is a long wait to hear whether they have gained approval, however, Mylan and Biocon will be kept busy by marketing and applications on three others biosimilars to pegfilgrastim, adalimumab and insulin glargine. The biosimilar to insulin glargine has already been accepted, in October of last year, by the EMA to treat type-2 diabetes and control high blood sugar for patients with type-1 diabetes. Biocon predicts this particular biosimilar will reach the fiercely competitive insulin US market by 2020.

Mylan President Rajiv Malik commented, "The FDA acceptance of our BLA for proposed biosimilar trastuzumab marks an important step toward increasing access to this treatment option for patients in the U.S. We believe that our comprehensive package of analytical similarity, non-clinical and clinical data submitted with the BLA will demonstrate similarity of the proposed biosimilar trastuzumab to the reference product. We are committed to bringing this product to market and look forward to working with FDA over the next months. This is Mylan and Biocon's first U.S. regulatory submission through the 351(k) pathway and reinforces the strength of our collaboration to increase access to a broad portfolio of high-quality, affordable biosimilars worldwide." 

Dr. Arun Chandavarkar, CEO and joint managing director of Biocon, said: "We are delighted by the FDA's acceptance of the BLA for our proposed biosimilar trastuzumab. It is a major milestone for the Mylan and Biocon collaboration since it is the first U.S. regulatory submission through our joint global biosimilars program. This development positions Biocon and Mylan among the first companies to be able to address the critical need of U.S. patients for a high-quality biosimilar to treat certain HER2-positive breast cancers in the near future."

Ben Hargreaves

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