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AAO Reacts to Ranibizumab Biosimilar Approval
The Center for Biosimilars® spoke with George Williams, MD, clinical spokesperson for the American Academy of Ophthalmology (AAO), about the FDA’s recent approval of Byooviz (ranibizumab), the first biosimilar specifically approved for treatment of eye diseases.
Tony Hagen, senior editor for The Center for Biosimilars®, speaks with George Williams, MD, clinical spokesperson for the American Academy of Ophthalmology (AAO), about the recent FDA approval of Byooviz (ranibizumab), a drug developed by Samsung Bioepis and slated for commercialization by Biogen. Byooviz references Lucentis.
Williams, who is also a past president of the AAO, discusses the value of a biosimilar ranibizumab for patients with eye conditions and the interest among eye disease specialists in having an additional option that improves treatment access, quality, and affordability.
He also addresses the available clinical evidence on this biosimilar and the anticipated delay before launch. Owing to a licensing agreement with the originator company, Genentech, Byooviz is unlikely to come to market before June 2022.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
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?
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
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.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
