Here are the top 5 biosimilar articles for the week of August 14, 2023.
Hi, I’m Skylar Jeremias 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 August 14, 2023.
Number 5: A Chinese study proved that combination therapy with sintilimab and a bevacizumab biosimilar was cost-effective enough in patients with hepatocellular carcinoma (HCC) to warrant use of the biosimilar over the reference product (Avastin) without compromising safety or efficacy.
Number 4: A study on the stability of the adalimumab biosimilar candidate TUR01, a tumor necrosis factor-α inhibitor, found long-term stability of the drug substance and drug product were maintained under different temperatures.
Number 3: The Spanish Psoriasis Working Group updated its position on the use of biosimilar medicines in patients with moderate to severe psoriasis, including its views on biosimilars as first-line treatment and nonmedical switching.
Number 2: Ranibizumab biosimilar was found to be the most cost-effective for neovascular age-related macular degeneration (nAMD), according to a recent Japanese study.
Number 1: Robert Zutaut, RPh, a clinical specialist from McKesson Provider Solutions, quantified the major barriers to adoption for biosimilars used to treat rheumatoid arthritis (RA) and some considerations for health systems looking to address them.
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.