The Top 5 Biosimilar Articles for the Week of August 15

Here are the top 5 biosimilar articles for the week of August 15, 2022.

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.

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