After coming to a settlement agreement (which may have been prodded by Amgen’s launch of Mvasi® in July), Pfizer can launch Zirabev® at the end of this year.
First reported by Aiden Fry at The Pink Sheet and confirmed by Kelly Davio at the Center for Biosimilars, the settlement between Genentech and Pfizer was signed September 19. It clears all remaining patent suits filed by Genentech (and its parent Roche), and if it follows the standard terms of previous agreements, pays a license to the maker of the reference product (Avastin®).
Amgen decided to launch Mvasi at-risk, gaining the advantage of being the first bevacizumab biosimilar available for prescription. The legal case brought by Genentech against Amgen hinges less on patent infringement but more on whether 6-month notice of launch was provided (or needed). The next step in this case is reportedly a trial sometime in 2020.
At least five other bevacizumab biosimilars are actively being investigated, but none of these are likely to be approved in 2020 (none have filed 351[k] applications to date).
