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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Number 1: The FDA released draft guidance on the design and evaluation of comparative analytical studies that are intended to support a demonstration of biosimilarity.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.
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.
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.
Health Canada Approves First Omalizumab Biosimilar
December 16th 2024Health Canada has approved Omlyclo, the first omalizumab biosimilar in Canada, for the treatment of chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, based on a phase 3 study confirming its bioequivalence to the reference product.
Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration
December 10th 2024Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.
Commercial Payer Coverage of Biosimilars: Market Share, Pricing, and Policy Shifts
December 4th 2024Researchers observe significant shifts in payer preferences for originator vs biosimilar products from 2017 to 2022, revealing growing payer interest in multiple product options, alongside the increasing market share of biosimilars, which contributed to notable reductions in both average sales prices and wholesale acquisition costs.
