Today's top healthcare news with a focus on the biosimilars industry.
1. Pfizer’s Humira Biosimilar Shows positive top line results: Pfizer’s second proposed inflammation biosimilar and the third proposed biosimilar pipeline molecule to report positive top-line results within the past four months.The Pfizer biosimilars pipeline consists of eight distinct biosimilar molecules in mid to late stage development, and several others in early stage development.
2. Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance: FDA will change Zarxio’s nonproprietary name from filgrastim-sndz to “filgrastim-bflm." And Amgen's Neupogen (filgrastim) would be changed to "filgrastim-jcwp."
3. FDA to review Biocon and Mylan's biosimilar drug for breast cancer: The US Food and Drug Administration (FDA) has accepted Mylan’s biologics license application (BLA) for the biosimilar, MYL-1401O, for review through the 351 (k) pathway.