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The Top 5 Biosimilars Articles for the Week of September 17
The Center for Biosimilars® recaps the top news for the week of September 17, 2018.
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 September 17.
Number 5: Chinese researchers are reporting positive preclinical results for a proposed cetuximab biosimilar.
Number 4: Mylan and Fujifilm have revealed that they will launch their adalimumab biosimilar in the European Union on or after October 16.
Number 3: The European Medicines Agency has published new materials intended to educate European patients about biosimilars.
Number 2: The Senate has passed a bill that would eliminate pharmacy gag clauses and require biosimilar and biologics developers to report patent settlements to the Federal Trade Commission.
Number 1: The State of California is suing AbbVie for allegedly using kickbacks and a network of nurses to illegally boost sales of Humira.
Finally, last week, our e-newsletter asked whether you think that interchangeability is the appropriate benchmark for pharmacy-level substitution.
To view 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.
