The Center for Biosimilars® recaps the top stories for the week of January 13, 2020.
Hi, I’m Christina Mattina 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 January 13, 2020.
Number 5: A recent study is the latest to find that Samsung Bioepis’ biosimilar SB4 works well for the majority of patients who switched from the originator etanercept, Enbrel.
Number 4: The Institute for Clinical and Economic Review released its final report on policy recommendations on the clinical effectiveness and economic value of Janus kinase (JAK) inhibitors for treating rheumatoid arthritis.
Number 3: Two studies recently reported on Hulio, the adalimumab biosimilar marketed and developed by Mylan and its partner Fujifilm Kyowa Kirin Biologics, saying it is equivalent to AbbVie’s reference adalimumab, sold as Humira.
Number 2: In the United States, recent analyses show that biosimilars achieved just 9%, or $91 million, of the $1 billion in cost savings that the Congressional Budget Office projected 10 years ago.
Number 1: An article in JAMA raises concerns that special and accelerated drug approval programs at the FDA may have resulted in a process that approves drugs based on weaker data, without reducing overall drug development time.
To read all of these articles and more, visit centerforbiosimilars.com.
Review Calls for Path to Global Harmonization of Biosimilar Development Regulations
March 17th 2025Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Comparable Pregnancy and Infant Milestones With Infliximab Biosimilars vs Originator in IBD
March 15th 2025A study evaluating pregnancy outcomes and infant developmental milestones found similar outcomes between pregnant women with inflammatory bowel disease (IBD) who received reference infliximab and those who received a biosimilar.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors
March 11th 2025The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.