Here are the top 5 biosimilar articles for the week of October 12, 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 October 12, 2020.
Number 5: As the United States continues to struggle to increase biosimilar uptake, presenters at the DIA 2020 Biosimilars Conference offered insight into what other countries have done to encourage biosimilar use.
Number 4:The sudden influx of coronavirus disease 2019 (COVID-19)–related trials work at the FDA has required judiciously pulling resources from various departments at the agency to support those efforts, according to Peter P. Stein, MD, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research (CDER).
Number 3: Celltrion Healthcare reported on progress with higher predose levels of the infliximab biosimilar Remsima in patients with Crohn disease (CD) and ulcerative colitis (UC).
Number 2: Celltrion Healthcare will initiate a phase 3 trial of its omalizumab biosimilar (CT-P39) candidate for the treatment of chronic idiopathic urticaria, a form of hives, based on a regulatory green light from the Republic of Korea’s Ministry of Food and Drug Safety.
Number 1: Most comparative efficacy trials conducted to obtain FDA approval for a biosimilar had a tendency to be larger, longer, and more costly than clinical trials required for originator products, according to a study of US biosimilar approvals prior to November 2019.
To read all of these articles and more, visit centerforbiosimilars.com.
AAM Report: Generics and Biosimilars Savings Reach $445 Billion in 2023, Part 1
September 18th 2024Savings from generic and biosimilar drugs totaled $445 billion in 2023, showing promise for the growth of both markets and highlighting the success of expansion policies for these products, according to a new report from the Association for Accessible Medicines (AAM).
Expanding Biosimilar Adoption: Insights and Strategies With Dr Sophia Humphreys
September 16th 2024Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses the challenges of expanding biosimilars into new therapeutic areas and highlights the role of education, competitive pricing, and integrated delivery networks in improving adoption and market growth.
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.
Real-World Study Shows Comparable Outcomes Between CT-P13, Remicade in RA
September 14th 2024A real-world study of the biosimilar infliximab-dyyb (CT-P13; Inflectra) in rheumatoid arthritis (RA) reported the majority of patients who initiated CT-P13 switched from the reference product (Remicade) or another biologic or targeted synthetic disease-modifying antirheumatic drug.
Comparable Disease Activity, Drug Persistence in Patients With JIA Who Switch to Biosimilars
September 12th 2024Switching children with juvenile idiopathic arthritis (JIA) from anti–tumor necrosis factor originators to biosimilars showed similar disease activity and drug persistence, with good tolerability, supporting the safety and effectiveness of non-medical switching.