The Top 5 Biosimilar Articles for the Week of January 29

Number 5: Authors of a review of available postapproval pharmacovigilance data assessing 8 Sandoz biosimilars concluded that these biosimilars “can be used as safely as their respective reference biologics.”

Number 4: A cross-sectional study, published on the JAMA Health Forum, found biosimilar use and market share higher in Medicare Advantage (MA) plans compared with traditional Medicare (TM) plans for most biosimilar products, except for bevacizumab.

Number 3: The FDA, Congress, biologic developers, and associations dedicated to evaluating the US biopharmaceutical space will need to work together to overcome challenges to biosimilar accessibility, says Sarfaraz K. Niazi, PhD, in his new column.

Number 2: A Korean health agency issued Samsung Bioepis an administrative penalty related to its biosimilar referencing Eylea (aflibercept); the FDA updates its labeling recommendations for interchangeable biosimilars; Alvotech receives another Form 483 after the FDA reinspected its Iceland-based manufacturing facility.

Number 1: On average, biosimilars obtain 53% market share in the first 3 years after initial launch; however, uptake speed continues to differ between treatment spaces, according to Samsung Bioepis’ Biosimilar Market Report for first quarter 2024 (Q1 2024).

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