The Top 5 Biosimilars Articles for the Week of July 13

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 biosimilars articles for the week of July 13, 2020.

Number 5: Biocon is planning to list its biosimilar entity, Biocon Biologics, on the capital markets in the next few years. Although this move will allow the entity to expand on current projects, it also raises questions about whether it will be successful.

Number 4: A monoclonal antibody from Biocon Biologics of Bengaluru, India, has been approved by the Drugs Controller General of India for the emergency treatment of acute respiratory distress syndrome (ARDS) in patients with coronavirus disease 2019 (COVID-19).

Number 3: Now is the time for the FDA to lead again in revising the biosimilar development guidance by eliminating all animal toxicology studies, and replacing them with larger-species pharmacokinetic (PK) studies, according to columnist Sarfaraz Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the College of Pharmacy at the University of Illinois at Chicago.

Number 2: The FDA has approved an adalimumab biosimilar (Hulio) from Fujifilm Kyowa Kirin Biologics, making it the sixth adalimumab biosimilar to AbbVie’s reference product Humira that has been approved and the 28th biosimilar approved by the FDA. Mylan will be handling the commercialization in the United States.

Number 1: Byoungseo Choi, head of marketing for Celltrion Healthcare, discusses how Celltrion's infliximab biosimilar can aid in the treatment of COVID-19—related inflammation, as well as the company’s launch plans for biosimilars through 2030.

To read all of these articles and more, visit centerforbiosimilars.com.