Here are the top 5 biosimilar articles for the week of February 28, 2022.
Hi, I’m Skylar Jeremias 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 biosimilar articles for the week of February 28, 2022.
Number 5: A report from the National Alliance of Healthcare Purchaser Coalitions detailed the common concerns employers have regarding implementing biosimilars within their health care plans and outlined how they could take charge and make a difference.
Number 4: Switching patients with Crohn disease from reference adalimumab to SB5, a Samsung Bioepis biosimilar, did not lead to major changes in disease activity in a real-world analysis.
Number 3: There remains risk in the US market due to regulatory and legal hurdles—not to mention a combative political environment, said executives during the “CEOs Unplugged” session at Access! 2022, held by the Association for Accessible Medicines (AAM) in Orlando.
Number 2: Prestige BioPharma has announced that the manufacturing facility for Tuznue, a proposed trastuzumab biosimilar, has received European Union (EU) Good Manufacturing Practices (GMP) certification.
Number 1: The FDA has accepted biologics license applications (BLAs) for interchangeability status from Alvotech and Pfizer regarding their respective adalimumab biosimilars referencing Humira.
To read all of these articles and more, visit centerforbiosimilars.com.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Achieving PFS in Advanced Gastric Cancer With HLX02 Biosimilar, Chemotherapy
November 23rd 2024In a phase 2 study, the addition of HLX22, an anti-HER2 antibody, to HLX02 biosimilar and XELOX (oxaliplatin and capecitabine) chemotherapy extended progression-free survival (PFS) in untreated HER2-positive advanced gastric cancer patients.
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.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.