News Briefs

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.

Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy (formerly called Specialty Pharmacy News) since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at HemAware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.

Related Posts

https://www.mmitnetwork.com/wp-content/uploads/2021/11/WordPress-Featured-Image-radar-on-specialty-pharmacy-Another-Immunotherapy-Indication-Will-Be-Withdrawn.jpg
November 16

FDA Grants Interchangeable Status to Humira Biosimilar; Payers Should Prepare Now for 2023 Launches

READ MORE
https://www.mmitnetwork.com/wp-content/uploads/2021/10/WordPress-Featured-Image_NSCLC.jpg
November 16

New Tecartus FDA Approval for Adults With ALL Offers Welcome Therapeutic Option

READ MORE
https://www.mmitnetwork.com/wp-content/uploads/2021/11/WordPress-Featured-Image-radar-on-specialty-pharmacy-Specialty-Trend-Increase-Slows-Biosimilars-Are-Having-Impact.jpg
November 16

Prime Therapeutics Launches IntegratedRx – Oncology, Partners on MIP Accreditation

READ MORE

GAIN THERAPEUTIC AREA-SPECIFIC INTEL TO DRIVE ACCESS FOR YOUR BRAND

Sign up for publications to get unmatched business intelligence delivered to your inbox.

subscribe today