The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 17, 2017.
Transcript:
Hi, I’m Kelly Davio for the Center for Biosimilars, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars. Here are our top 5 biosimilars articles for the week of July 17:
Number 5: A new report shows that most US-based health plans now cover at least 1 of the 2 available FDA-approved biosimilars.
Number 4: A phase 3 trial of the proposed rituximab biosimilar candidate GP2013 shows positive results in patients with follicular lymphoma.
Number 3: Molly Billstein Leber, manager of Medication Policy and Formulary Management for the Yale New Haven Health System, discusses the FDA’s Oncologic Drugs Advisory Committee’s unanimous recommendation of approval for biosimilars to Avastin and Herceptin.
Number 2: At this week’s public meeting on the Hatch-Waxman Amendments, FDA Commissioner Dr Scott Gottlieb announced the upcoming publication of 2 documents related to the ANDA process.
And finally, Number 1: The FDA Reauthorization Act may proceed to a Senate vote sooner rather than later after the failure of the Better Care Reconciliation Act.
Read these articles and more at centerforbiosimilars.com
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
A Banner Year for Biosimilars: The 19 FDA Approvals From 2024
January 21st 2025In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.
FTC Releases Second Report on PBMs Meddling in Generic Drug Markets
January 19th 2025The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.