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The Top 5 Biosimilars Articles for the Week of November 27
The Center for Biosimilars recaps the top 5 articles for the week of November 27.
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 November 27.
Number 5: The World Health Organization has a released a new report that estimates that 1 in 10 drugs worldwide is either falsified or substandard, leading to unnecessary deaths and increased costs to patients and health systems.
Number 4: German drug maker Formycon projects that its biosimilar challenger to Lucentis will be launched in the US market in 2020.
Number 3: The FDA has begun to add 4-letter suffixes, devoid of meaning, to the nonproprietary names of newly approved biologics.
Number 2: Contributor Brian Lehman explains the potential impact of CMS’ proposed rule that would treat biosimilars as generic drugs for the purpose of cost-sharing under Medicare Part D.
Number 1: The FDA has approved Mylan and Biocon’s trastuzumab biosimilar, referenced on Herceptin.
Finally, last week, our e-newsletter asked whether you think that innovative device design will play a role in reference product sponsors’ defense strategies against biosimilar competition. To see results of the poll, visit us on LinkedIn.
To read all of 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.
