Mylan Files Application for First Herceptin® Biosimilar

Stan R. Mehr

Partners Mylan and Biocon announced on November 9 that their 351(k) application for a biosimilar version of trastuzumab has been filed with the US Food and Drug Administration (FDA). This filing of MYL-1401O marks several firsts: the first biosimilar application for this product, the first biosimilar filing for an agent that directly treats cancer, and the first 351(k) filing for the Mylan—Biocon partnership.

Mylan president, Rajiv Malik, stated in a press release, “Our trastuzumab biosimilar is already being sold in 11 developing markets, including India, and we look forward to bringing the product to market in the US and Europe upon approval.” Biocon’s CEO, Arun Chandavarkar, added, “The submission of our proposed biosimilar trastuzumab with the FDA is an important milestone of Biocon and Mylan's joint, global biosimilars program and demonstrates our commitment to provide access to high-quality and affordable biologics to patients across the globe.”

The Mylan—Biocon partnership aims to develop and market 6 possible biosimilar molecules. Mylan has exclusive commercialization rights in several regions, including North America, Australia, and Europe.

The global market for Herceptin stands at $6.6 billion, and it is a stalwart revenue producer for Roche. Mylan and Biocon will likely face additional competitors fairly soon, as Celltrion and Samsung Bioepis have already filed trastuzumab applications with the EMA, and Amgen is moving quickly to develop their own version.

Currently, the only cancer-related products that have been filed or approved have been for supportive care (epoetin, filgrastim, and pegfilgrastim. Additional oncology therapeutics are being investigated, but not yet filed with the FDA, and include rituximab and bevacizumab.