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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.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
What Clinicians Need to Know About Using Biosimilars to Treat IBD
April 13th 2024A review article, intended to act as a guide for clinicians, summarizes the available infliximab and adalimumab biosimilars for treating inflammatory bowel disease (IBD) as well as others that are coming down the pipeline.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.
