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Clinical Trial Roundup Episode 1
Here is a collection of some of our most recent clinical trial news articles.
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 is a collection of some of our most recent clinical trial news articles.
In search of effective treatments for patients hospitalized with coronavirus disease 2019 (COVID-19), investigators will test an infliximab biosimilar (Remsima, CT-P13). They believe it may help to control cytokine release syndrome, which is associated with COVID-19.
Celltrion Healthcare also reported positive results for its infliximab biosimilar in several studies presented at the European League Against Rheumatism's European E-Congress of Rheumatology 2020.
The studies concerned the influence of body mass on response for CT-P13 subcutaneous (SC) in patients with active rheumatoid arthritis, the correlation between antidrug antibody positivity and clinical outcomes in patients with RA, and the potential savings in a market scenario where patients are treated with CT-P13 SC.
Biosimilar trastuzumab (Herzuma) in combination with pembrolizumab and chemotherapy was highly effective in reducing tumor size in patients with HER2-positive advanced gastric cancer, according to results of a phase 1b/2 clinical trial.
Shanghai Henlius Biotech said a trial of its bevacizumab biosimilar candidate HLX04 met its primary end point of progression-free survival at 9 months in patients with metastatic colorectal cancer.
An extension study of a trastuzumab biosimilar (SB3, Ontruzant) versus reference trastuzumab (TRZ) supports a hypothesis that a downward "drift" in antibody-dependent cell-mediated cytotoxicity contributed to lower event-free survival and overall survival, according to data presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.
A phase 3 clinical trial comparing the safety, efficacy, and immunogenicity of Samsung Bioepis’ aflibercept biosimilar with reference Eylea in patients with neovascular age-related macular degeneration is now underway.
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.
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?
Biosimilars Gastroenterology Roundup: March 2025
April 1st 2025As the biosimilar industry celebrates a decade of growth, the market continues to evolve with expanded treatment options, cost savings, and a flurry of new competitors—yet regulatory challenges, market dynamics, and patient accessibility remain key hurdles to unlocking its full potential.
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
March 30th 2025Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, predict pharmacy benefit managers (PBMs) will evolve toward value-based care, mirroring the broader shift toward open-cost structures.
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.
