The Top 5 Biosimilar Articles for the Week of October 12

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.