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The Top 5 Biosimilars Articles for the Week of January 15
The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 15, 2018.
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 January 15.
Number 5: The United Kingdom’s Medicines and Healthcare Products Regulatory Agency announced that it will not make any sudden changes to the nation’s regulatory framework following Brexit.
Number 4: A newly published study found that pediatric patients with Crohn disease who received early combination therapy with infliximab and azathioprine had significantly increased linear growth compared with patients who received step-up therapy.
Number 3: Several European nations are amending their policies in order to create better conditions for biosimilar uptake.
Number 2: Sandoz announced that the FDA has accepted its Biologics License Application for a proposed adalimumab biosimilar.
Number 1: The Medicare Payment Advisory Commission called for changes to Medicare Part D to remove financial disincentives that block the use of lower-cost biosimilar therapies.
Finally, last week, our e-newsletter asked whether you think that Congress should revisit legislative solutions to the problem of high drug prices. To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
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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.
