Mylan Submits Filing of Biosimilar Herceptin to FDA
Mylan, with its partner Biocon, a Bangalore, India-based biotechnology company, have submitted Mylan’s biologics license application to the US Food and Drug Administration (FDA) for MYL-1401O, a proposed biosimilar of Roche’s anti-cancer drug, Herceptin (trastuzumab), which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan’s trastuzumab biosimilar is already being sold in 11 developing markets, including India, the company said.
Roche’s Herceptin is one of Roche’s top-selling drugs with 2015 global sales of CHF 6.54 billion ($6.84 billion) and sales of CHF 5.13 billion ($5.24 billion) in for the nine months ended September 30, 2016.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar products and insulin analogs. The proposed biosimilar trastuzumab is one of six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand, and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.
Last week, Mylan, with its partnership with Biocon, submitted a filing to the European Medicines Agency for insulin glargine, a long-acting insulin product that references Sanofi’s Lantus, Sanofi’s top-selling drug with 2015 global sales of EUR 6.4 billion ($7.1 billion).