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.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis
October 19th 2024A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17(Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.
Revolutionizing Biopharmaceuticals: The EU's Biosimilar Success and Remaining Challenges
October 16th 2024The European Union's (EU) approach to biosimilars has revolutionized the biopharmaceutical market by driving innovation, lowering costs, and increasing adoption; however, there remains a need for more education, real-world evidence, and efforts to address challenges to enhance patient access and affordability.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.