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The Top 5 Biosimilars Articles for the Week of May 20
The Center for Biosimilars® recaps the top news for the week of May 20, 2019.
Transcript
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Number 1: The FDA released draft guidance on the design and evaluation of comparative analytical studies that are intended to support a demonstration of biosimilarity.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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.
