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Number 1: The FDA released draft guidance on the design and evaluation of comparative analytical studies that are intended to support a demonstration of biosimilarity.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.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Biosimilars Regulatory Roundup for September 2023—Podcast Edition
October 1st 2023On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Part 3: Study Questions Usefulness of Clinical Efficacy Trials for Oncology Biosimilars in Europe
November 16th 2023In part 3 of a 3-part series for Global Biosimilars Week, The Center for Biosimilars® reviews an analysis investigating whether clinical efficacy studies have an impact on prescribing decisions for oncology biosimilars across Europe.
Eye on Pharma: Denosumab Biosimilar Data; COA Forms New Committee; IGBA and WHO Collaborate
November 8th 2023Samsung Bioepis releases data for its denosumab biosimilar candidate; the Community Oncology Alliance (COA) forms the Drug Policy and Regulation Committee; the International Generic and Biosimilar Association (IGBA) and the World Health Organization (WHO) collaborate on a new initiative.
