Here are the top 5 biosimilar articles for the week of December 19, 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 December 19, 2022.
Number 5: The FDA has accepted Biogen’s biologics license application for a biosimilar candidate (BIIB800) referencing Actemra (tocilizumab) for review. If approved, the drug will be used to treat several conditions, including rheumatoid arthritis, idiopathic polyarthritis, idiopathic arthritis, and sclerosis-associated interstitial lung disease.
Number 4: A phase 1 study in China found that pharmacokinetics, safety, and immunogenicity were similar between the liraglutide biosimilar RD12014 and the reference product (Victoza) in healthy male participants.
Number 3: Despite recent steps taken by the FDA to streamline approvals and increase availability for biosimilars, biosimilar adoption has been slow and primarily driven by payers in the United States, signaling that more needs to be done to encourage adoption, according to experts at a virtual workshop hosted by the FDA and the University of Maryland.
Number 2: Johnson & Johnson’s Janssen unit filed a lawsuit against Amgen, claiming the latter infringed on the former’s patents when creating its ustekinumab biosimilar, and Express Scripts announced that it would add adalimumab biosimilars to formulary.
Number 1: Fresenius Kabi announced the FDA approval of its adalimumab biosimilar Idacio (adalimumab-aacf), making it the eighth biosimilar referencing Humira (adalimumab) to be approved in the United States.
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.