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The Top 5 Biosimilar Articles for the Week of March 14
Here are the top 5 biosimilar articles for the week of March 14, 2022.
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 March 14, 2022.
Number 5: Europe’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for 2 insulin biosimilars, meaning that the agency has recommended the European Commission grant them marketing authorization.
Number 4: Health Canada has approved Byooviz, a biosimilar referencing Lucentis (ranibizumab), for the treatment for several ophthalmic conditions. Byooviz represents the first ranibizumab biosimilar to be approved for the Canadian market.
Number 3: Teva Pharmaceuticals launched lenalidomide capsules, the generic of Revlimid, in the United States. The capsules are available in 5 mg, 10 mg, 15 mg, and 25 mg strengths, according to a statement from the company.
Number 2: AbbVie settled outstanding lawsuits, including its case related to the International Trade Commission (ITC), with Alvotech, giving Alvotech the green light to launch its high-concentration, citrate-free adalimumab biosimilar referencing Humira in July 2023, pending FDA approval.
Number 1: At a session at the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit, panelists suggested that the quest for rebates by pharmacy benefit managers (PBMs) prevents uptake on some biosimilars—and could soon bleed over into biosimilar formulary placement.
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.
