Mylan and Biocon's biosimilar for Herceptin also is under review in Australia, Canada, Europe and several additional markets. The biosimilar trastuzumab or Ogivri is one of the six biologic products co-developed by the companies. This milestone secured a clear pathway to commercialize Mylan's biosimilar to Herceptin in various markets globally, stated the company release.
To gain approval, the FDA reviewed evidence of Ogivri including: animal study data, structural and functional characterization, pharmacokinetic and pharmacodynamics data and clinical safety data.
Ogivri is already approved in 19 countries around the world, and Mylan and Biocon are now working with regulatory authorities in Australia, Canada, and Europe for approval for the Herceptin biosimilar.
According to, CEO, Mylan said the approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the United States healthcare system.
"This approval represents a landmark achievement for the Biocon-Mylan collaboration and is an important endorsement of our development and manufacturing capabilities in the area of monoclonal antibodies", said Arun Chandavarkar, chief executive officer and joint managing director of Biocon. Biocon expects revenue from its biologics portfolio in regulated markets such as the USA and Europe to kick in from next fiscal. It is already approved in 19 countries around the world, including India.
Annual sales of the Roche's cancer medicines - Rituxan, Herceptin and Avastin - top $21 billion, or more than half of its pharmaceuticals business, but are under threat as their biosimilar versions get approval. "Ogivri is the first biosimilar approved in the USA for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the United States for the treatment of cancer [the first was Amgen's Mvasi (bevacizumab-awwb), approved in September as biosimilar to Roche's cancer treatment Avastin (bevacizumab) though neither are interchangeable biosimilars]".