The Center for Biosimilars recaps the the top 5 articles for the week of December 18, 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 the top 5 biosimilars articles for the week of December 18.
Number 5: A newly published study shows that adalimumab is effective in treating stricturing Crohn disease.
Number 4: Mylan announced that the US Patent Trial and Appeal Board has instituted inter partes review proceedings on all claims against 2 patents covering Sanofi’s Lantus.
Number 3: Tax disclosures show that industry group PhRMA spent millions on lobbyists, politicians, and patient groups in 2016.
Number 2: Attorney Kevin Nelson, partner at Schiff Hardin, explained the impact that the federal circuit’s ruling in Amgen v Sandoz will have on biosimilar developers.
Number 1: The FDA has accepted for review Samsung Bioepis’ Biologics License Application for SB3, a proposed trastuzumab biosimilar.
Finally, last week, our e-newsletter asked whether you think that the FDA has become more lenient in approving drugs under current leadership. To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.