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The Top 5 Biosimilar Articles for the Week of September 21
Here are the top 5 biosimilar articles for the week of September 21, 2020.
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 September 21, 2020.
Number 5: Expanded indications have been approved for Merck’s Brenzys etanercept biosimilar by Health Canada to include plaque psoriasis, psoriatic arthritis, and juvenile idiopathic arthritis.
Number 4: After receiving positive results from a phase 1 trial for its coronavirus disease 2019 (COVID-19) monoclonal antibody treatment (CT-P59), Celltrion Healthcare has received approval to initiate a phase 2/3 trial.
Number 3: The American College of Physicians (ACP) said many reforms are needed to install appropriate checks and balances in the biologic drugs marketplace.
Number 2: Positive pharmacokinetic (PK) equivalency data were presented for PrestigePharma’s trastuzumab biosimilar candidate, at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Number 1: Much of the groundwork for establishing equivalence is established in the pharmacokinetic evaluation. Further studies add less and less to the body of evidence for biosimilar approval, UK regulators write.
To read all of these articles and more, visit centerforbiosimilars.com.
Biosimilar Policy Roundup—September 2024
October 1st 2024In September 2024, the FDA approved a new biosimilar for treating retinal conditions, marking a significant development in the biosimilars landscape, coinciding with ongoing legal disputes in the industry and highlighting broader trends in market dynamics and regulatory challenges.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Patient-Reported Outcomes Similar Between Adalimumab-adbm, Reference Product in VOLTAIRE-RA Study
September 28th 2024A summary of research written by Vibeke Strand, MD, clinical professor in division of immunology/rheumatology at Stanford University School of Medicine, gave an overview of patient-reported outcomes (PROs) in the VOLTAIRE-RA trial.
