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The Top 5 Biosimilar Articles for the Week of April 24
Here are the top 5 biosimilar articles for the week of April 24, 2023.
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 April 24, 2023.
Number 5: A study assessing factors that may determine a commercial health plan’s likelihood of covering a biosimilar found that biosimilars that are cancer therapies, used to treat children, indicated for highly prevalent conditions, or only competing against the originator were more likely to have coverage restrictions.
Number 4: Celltrion Healthcare shared data from a phase 3 clinical trial confirming that its omalizumab biosimilar had comparable safety and efficacy to the reference product (Xolair).
Number 3: A retrospective study in Scotland found that multiple successive changes from originator infliximab to biosimilars seem to be safe and effective in patients with inflammatory bowel disease (IBD), irrespective of the number of switches.
Number 2: In a complete response letter (CRL) for Alvotech, the FDA cited “deficiencies” in the company’s manufacturing facility during a reinspection, further delaying the approval for the ninth adalimumab biosimilar until potentially June 2023.
Number 1: The misconceptions about disposable bioreactors' lifecycle are gone; the era of hard-piped, giant, stainless-steel tanks for biosimilar development is history now, according to Sarfaraz K. Niazi, PhD, in his latest column.
To read all of these articles and more, visit centerforbiosimilars.com.
Ranibizumab Biosimilar Shows Reduced Efficacy vs Aflibercept in nAMD
April 3rd 2025The ranibizumab biosimilar Ongavia exhibited significantly less improvement in visual acuity and retinal thickness compared with aflibercept (Eylea) in treating neovascular age-related macular degeneration (nAMD), highlighting a potential trade-off between economic savings and clinical efficacy.
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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.
PBM Evolution Toward Value-Based Care Shifts to Transparent Pharmacy Pricing
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FDA Approves Another Pair of Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for osteoporosis, bone metastases, and other bone-related conditions, amidst a flurry of similar approvals and legal settlements.
