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The Top 5 Biosimilars Articles for the Week of March 19
The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of March 19, 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 March 19.
Number 5: In the latest episode of our podcast, “Not So Different,” Christine Simmon of the Biosimilars Council explains why her organization supports the CREATES Act.
Number 4: Celltrion has granted marketing rights for its trastuzumab in 7 European nations to Mundipharma.
Number 3: A recent study showed that patients with rheumatoid arthritis who use infliximab have a higher discontinuation rate due to disease remission than those patients who use other biologics.
Number 2: The FDA’s Center for Drug Evaluation and Research has launched its pilot effort to publicly release clinical study report data from pivotal clinical trials.
Number 1: An insurer is backing away from a plan to institute a nonmedical switch from brand-name Remicade to biosimilar Inflectra.
Finally, last week, our e-newsletter asked for your thoughts on which stakeholder group has the most influence on biosimilar acceptance.
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.
