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The Top 5 Biosimilars Articles for the Week of May 14
The Center for Biosimilars® recaps the top 5 articles for the week of May 14, 2018.
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 May 14.
Number 5: The President’s plan to reduce drug prices for Americans includes asking FDA to issue guidance on possible abuse of safety programs to delay generic or biosimilar competition.
Number 4: Pfenex has announced positive top-line results from a phase 3 study of its follow-on teriparatide, referencing Forteo, a recombinant human parathyroid hormone.
Number 3: A study of pregnant patients treated with biosimilar infliximab for inflammatory bowel disease found that the biosimilar was not associated with any new safety concerns.
Number 2: CMS has released updated versions of its Drug Spending Dashboards, and data included show that prices are on the rise for drugs that have existing or upcoming biosimilar competition.
Number 1: The FDA has approved Pfizer’s epoetin alfa biosimilar, Retacrit, which the company is preparing to launch in 2018.
Finally, last week, our e-newsletter asked for your thoughts on which approach to biosimilar education is likely to have the biggest impact.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.
BioRationality: FDA Clarification Provides New Indications and Process Change for Biosimilars
September 9th 2024Sarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential for biosimilars to introduce new indications or formulation changes, which could significantly impact their market competitiveness and accessibility.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
BioRationality: FDA Opens Up Biosimilar Inquiries on Reddit
August 26th 2024Sarfaraz K. Niazi, PhD, urges stakeholders to engage with the FDA on its Reddit forum—where a representative will answer complex biosimilar questions—encourages clearing misconceptions, and advocates for updates to the Biologics Price Competition and Innovation Act guidelines.
Eye on Pharma: Celltrion, Costco Partnership; Amgen Sues Samsung Bioepis; Denosumab Results
August 21st 2024Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.
