Here are the top 5 biosimilar articles for the week of September 25, 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 September 25th, 2023.
Number 5: Although removing the requirement for clinical efficacy testing for biosimilar approval would reduce development costs of biosimilars, representatives from several biosimilar manufacturers argued in the second day of the FDA’s development workshop that clinical outcomes will not be affected.
Number 4: Drug maker payments to ophthalmologists were associated with the choice of higher-cost therapies for age-related macular degeneration (ARMD) that could increase Medicare costs, but biosimilars could help.
Number 3: A study evaluating the real-world impact of treating patients with inflammatory bowel disease (IBD) with an adalimumab biosimilar found that providing patient questionnaires early can be useful for identifying those at a higher risk of treatment discontinuation.
Number 2: The European Commission approved the first aflibercept biosimilar, which will be used to treat patients with age-related macular degeneration and diabetic macular edema.
Number 1: In the final part of a 3-part series, Sarfaraz K. Niazi, PhD, gave his take on the FDA's recent workshop dedicated to streamlining biosimilar development and his opinion on what the industry can learn from the webinar presenters.
To read all of these articles and more, visit centerforbiosimilars.com.