Here are the top 5 biosimilar articles for the week of May 17, 2021.
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 May 17, 2021.
Number 5: Various House members have asked the Federal Trade Commission (FTC) to open an antitrust investigation into pharmaceutical giant AbbVie, which allegedly has exceeded its patent rights in preventing biosimilar competition to arthritis drug Humira (adalimumab) in the United States.
Number 4: Investigators in Germany said that a comparison of adalimumab biosimilar (Amgevita) vs originator (Humira) treatment for patients with rheumatoid arthritis has demonstrated significant cost savings for earlier treatment overall.
Number 3: Sandoz has lost a bid to bring its etanercept biosimilar to market before 2029, as the Supreme Court declined to review the company’s petition to invalidate 2 patents held by Amgen for the reference drug, Enbrel.
Number 2: With the pandemic tapering off in the United States and its sales force vaccinated, Coherus BioSciences hopes that returning its sales representatives to the field this spring will counter relatively flat sales of its pegfilgrastim biosimilar (Udenyca).
Number 1: The FDA’s interchangeability designation for biosimilars was intended to improve uptake and acceptance of these agents, but so far it has created misperception and confusion, according to Albert Kim, MBA, vice president of the Commercial Division at Samsung Bioepis.
To read all of these articles and more, visit centerforbiosimilars.com.
Real-World Data Confirm Safety of Switching Between Ranibizumab Biosimilars
March 19th 2025Patients with diabetic macular edema previously treated with a ranibizumab biosimilar in India experience comparable safety and efficacy after being switched to another ranibizumab biosimilar, demonstrating real-world safety of biosimilar-to-biosimilar switching.
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?
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.
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.
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.