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The Top 5 Biosimilars Articles for the Week of November 13
The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of November 13.
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 13.
Number 5: Intragovernmental organization The South Centre has released a paper that calls on regulatory bodies to approve “biological generics” rather than biosimilars.
Number 4: At the SMi Biosimilars North America 2017 conference, a Mylan executive warned that reference product sponsors may be involved in a “whisper campaign” against biosimilars.
Number 3: A recent review identified patient-, disease-, and treatment-related factors that may predict response to anti—tumor necrosis factor therapies.
Number 2: Contributor Sonia T. Oskouei breaks down the key facts that biosimilar stakeholders need to know about CMS’ recent change in biosimilar reimbursement policy.
Number 1: Two major biosimilar patent litigation cases came to a close in recent days, with the ruling Amgen v Apotex upheld in an appellate court, and with Janssen dropping its suit against biosimilar developer Samsung Bioepis.
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.
