Here are the top 5 biosimilar articles for the week of March 13, 2023.
Hi, I’m Justina Petrullo 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 March 13th, 2023.
Number 5: In part 2 of this 2-part series, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, continued to examine guidelines from the World Health Organization (WHO) and how they view interchangeability and animal study requirements.
Number 4: Coherus Biosicences announced that the FDA approved a single-dose, prefilled autojector version of its pegfilgrastim biosimilar (Udenyca; pegfilgrastim-cbqv), for the treatment and prevention of febrile neutropenia, a common complication related to chemotherapy treatment.
Number 3: Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.
Number 2: A white paper touting biosimilar successes in the United States reasoned that increased market competition will help improve utilization rates, generate substantial savings, and encourage payers to cover biosimilars.
Number 1: The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.
To read all of these articles and more, visit centerforbiosimilars.com.