The Top 5 Biosimilar Articles for the Week of August 15

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 August 15, 2022.

Number 5: The FDA approval of Samsung Bioepis’ high-concentration, citrate-free formulation of Hadlima, a biosimilar referencing Humira (adalimumab), is the first high-concentration adalimumab biosimilar to be approved in the United States.

Number 4: Celltrion Healthcare set its sights on obtaining an interchangeability designation for its adalimumab biosimilar, and Formycon released positive findings from a phase 3 trial involving its ustekinumab biosimilar.

Number 3: Researchers found that the percentage of biosimilar uptake is a better predictor of whether prices of biologics will significantly decrease, refuting the argument that more biosimilars for a single reference product will have the biggest impact.

Number 2: Sarfaraz K. Niazi, PhD, a professor, entrepreneur, and biosimilar advocate, took aim at criticisms of the Inflation Reduction Act of 2022 that was signed into law and critiques the argument that the bill should be considered a “price control” measure. In response, Craig Burton, from the Association for Accessible Medicines, argued that the Inflation Reduction Act of 2022 could prevent biosimilar competition, and decreased drug prices as a result.

Number 1: Study authors found that FDA-approved adalimumab biosimilars, Hulio and Hyrimoz, were safe and effective in treating patients with inflammatory bowel disease. (IBD). However, they were not as effective as infliximab products.

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