Here are the top 5 biosimilar articles for the week of July 25, 2022.
Hi, I’m Hayden Klein 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 biosimilar articles for the week of July 25, 2022.
Number 5: The first 2 years of a Providence St. Joseph Health program to increase biosimilar uptake and cut costs created $26.9 million in cost savings and “biosimilar adoption rates that greatly exceed the US national average.”
Number 4: Alvotech announced early Wednesday it will launch a pharmacokinetic (PK) study of AVT03, a proposed biosimilar for 2 different formulations of denosumab, which is used to treat serious bone conditions.
Number 3: Prestige Biopharma and Intas Pharmaceuticals joined forces to partner on a bevacizumab biosimilar for multiple countries, and Hikma Pharmaceuticals made a deal with Celltrion Healthcare for the commercialization of an adalimumab biosimilar.
Number 2: Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were accepted for review by the FDA and the European Medicines Agency.
Number 1: In recent weeks, Celltrion Healthcare furthered its adalimumab biosimilar (Yuflyma) by launching the drug in Spain and Portugal and starting a clinical trial in France while Xbrane Biopharma provided an update on the FDA filing of its ranibizumab biosimilar.
To read all of these articles and more, visit centerforbiosimilars.com.
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.
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.
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.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.