- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Top 5 Biosimilar Articles for the Week of October 12
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.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.
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?
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
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.
