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The Top 5 Biosimilars Articles for the Week of August 14
The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 14, 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 August 14.
Number 5: Biocon has withdrawn its filings for 2 biosimilars in Europe ahead of a re-inspection of its Bangalore manufacturing facility. The move sparked new questions as to whether the company’s trastuzumab will be cleared by the FDA next month.
Number 4: Dr Marcus Snow, of the University of Nebraska Medical Center, joined The Center for Biosimilars® to discuss the use of biosimilar treatments in children.
Number 3: With drug price reform efforts apparently stalled at the federal level, states are leading the fight against rising drug costs.
Number 2: A recent budget impact analysis shows that discounts for biosimilar infliximab may need to be deeper than previously believed in order to encourage uptake.
And Number 1: Rebates provided to PBMs by reference product sponsors may pose a threat to biosimilar uptake, and could force patients to pay high out-of-pocket costs.
Finally, last week, our newsletter asked you to share your thoughts on switching studies, and whether such studies should use a US-licensed reference product, an EU-licensed product, or a product approved by any global healthcare agency. To view results of the poll, follow The Center for Biosimilars® on LinkedIn.
To read these articles and more, visit centerforbiosimilars.com.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
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.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
