• The US FDA approved Amgen’s Mvasi in Sept’2017 with its notice of commercial marketing to Genentech in Oct’2017 indicating its launch post 180 days after the letter’s date
• Amgen filed no. of supplements in accordance of its BLA with the FDA- including changes to the labeling for the biosimilar while Genentech addressed it as a different product approved in reference to 2017 the US FDA approval further prohibiting Amgen from marketing the biosimilar until 180 days post filing a new notice of commercial marketing
• The Federal Circuit dismiss with Genentech addressing the original product approved is same as the product for which supplements to the BLA were also approved. Additionally- Genentech appealed for injunction on sales of Mvasi in the US on which the Federal Circuit explained the four factors of injunction leading to disagreement halting sales of Amgen’s Mvasi

Click here to read full press release/ article | Ref: Biomolecules | Image: Twitter