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Mylan Files Application for First Herceptin® Biosimilar
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.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
FDA Approves Celltrion's Avtozma as Third Tocilizumab Biosimilar
January 31st 2025The FDA approved Avtozma, a tocilizumab biosimilar developed by Celltrion, for the treatment of several rheumatic conditions. It is the third biosimilar to reference Actemra (tocilizumab) to be approved for US patients.
