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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Number 1: The FDA released draft guidance on the design and evaluation of comparative analytical studies that are intended to support a demonstration of biosimilarity.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.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
BioRationality: Commemorating the 15th Anniversary of the BPCIA
April 8th 2025Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.
