✦ A federal circuit court ruled July 6 that Amgen Inc. gave adequate notice to Roche Group unit Genentech USA, Inc. before commercializing its Mvasi (bevacizumab-awwb), a biosimilar to Genentech’s Avastin (bevacizumab). The U.S. Court of Appeals for the Federal Circuit upheld an opinion (No. 1:19-cv-00602-CFC) from the U.S. District Court for the District of Delaware that Amgen had complied with the provision of the Biologics Price Competition and Innovation Act (BPCIA) requiring biosimilar companies to provide 180 days’ notice to the innovator company notifying the innovator of their intent to commercially market a biosimilar. Genentech claimed that Amgen had not done this for supplements to its Mvasi application and had filed an emergency motion and a motion for a temporary restraining order. According to the ruling, “Amgen notified Genentech of its intent to commercially market its biological product, Mvasi, on October 6, 2017. Despite its later supplements to its applications adding a manufacturing facility and changing its drug product label, Amgen’s biological product, Mvasi, did not change. Genentech, therefore, had notice of Amgen’s intent to commercially market Mvasi as required.” View the decision at https://bit.ly/3gAULCw.
✦ Mylan N.V. said June 18 that a district court had invalidated a Biogen patent for its multiple sclerosis drug Tecfidera (dimethyl fumarate). The move clears the way, said Mylan, for it to launch its dimethyl fumarate product after the FDA approves it. The drug’s action date is Nov. 16, and Mylan said it is working with the FDA to move up that date. Mylan said it believes its application is one of the first filed for this product, and thus it expects to receive 180 days of marketing exclusivity once it launches. According to Fierce Pharma, Biogen will appeal the decision. View the decision at http://freepdfhosting.com/05a5211020.pdf.