The Center for Biosimilars® recaps the top news for the week of May 20, 2019.
Hi, I’m Samantha DiGrande 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 May 20.
Number 5: During the Digestive Disease Week 2019 meeting, researchers presented 1-year results of a phase 1 trial of subcutaneous CT-P13 in patients with Crohn disease.
Number 4: Treatment with Fresenius Kabi’s biosimilar adalimumab resulted in comparable quality of life improvements to treatment with the reference, according to a new study.
Number 3: During the ISPOR 2019 annual meeting, teams of investigators presented data estimating how much multiple EU countries could save by adopting biosimilar adalimumab.
Number 2: CMS has issued a final rule that makes changes to Medicare Advantage and Medicare Parts D and B.
Number 1: The FDA released draft guidance on the design and evaluation of comparative analytical studies that are intended to support a demonstration of biosimilarity.
Finally, last week, our e-newsletter asked whether you think the FDA’s final guidance on interchangeability provides developers with enough clarity.
To view results of the poll, visit us on LinkedIn.
To read all of these articles and more, visit centerforbiosimilars.com.