The Center for Biosimilars® recaps the top news for the week of February 18, 2019.
Transcript:
Hi, I’m Samantha DiGrande 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 February 18.
Number 5: A study of cost trends for tumor necrosis factor inhibitors after the entry of new competition showed that the newer drugs did not lower costs, and in fact, the annual treatment costs of the existing medicines rose substantially.
Number 4: Health Canada has announced that all biologics, including biosimilars, will be identified by their brand names and nonproprietary names without the addition of a product-specific suffix.
Number 3: Among comments from stakeholders on the FDA’s proposed approach to transition insulins to regulation as biologics is a suggestion that one drug maker may be interested in selling biosimilars of its own products.
Number 2: Biosimilar developer Sandoz announced the launch of its biosimilar adalimumab, Hyrimoz, in Spain.
Number 1: Pfizer received authorization from the European Commission for its bevacizumab biosimilar, Zirabev.
Finally, last week, our e-newsletter asked whether you think that HHS’ proposal to do away with rebates will lead to higher out-of-pocket costs for Medicare beneficiaries.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
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.
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.
Unifying Standards: The Need for Streamlined Biosimilar Development
October 22nd 2024At the 2024 GRx+Biosims conference, industry leaders and regulatory experts underscored the urgency of unifying global standards and simplifying the biosimilar development process, sharing insights on recent advancements and the necessity for greater collaboration between manufacturers and regulatory agencies.
Cost Savings and Efficacy of Biosimilars in Psoriasis Treatment for Veterans
October 17th 2024Biosimilars are safe, effective, and well-tolerated for psoriasis treatment, providing significant cost savings for the Veterans Health Administration, which saved over $67 million in 2023, while highlighting ongoing provider concerns regarding their use.