Here are the top 5 biosimilar articles for the week of May 16, 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 May 16, 2022.
Number 5: Posters from the Academy of Managed Care Pharmacy (AMCP)’s annual meeting examined the real-world patterns of biosimilar utilization and the impact of products that have been reclassified as biologics on Medicaid spending.
Number 4: A new bill that would amend the Federal Food, Drug, and Cosmetic Act aims to expand FDA user fee programs for prescription drugs and medical devices, including biosimilars and generics.
Number 3: Biocon’s total revenue for the fourth quarter of the 2022 fiscal year was up 21% from the same period in the prior year, largely due to significant growth in sales for the company’s biosimilar and generic drugs.
Number 2: The United Kingdom has approved Teva Pharmaceutical’s biosimilar (Ongavia), which references Lucentis (ranibizumab), for the treatment of several ophthalmic conditions.
Number 1: In a pharmacokinetic study, Alvotech’s ustekinumab biosimilar referencing Stelara was shown to have comparable safety and efficacy to the reference product, according to the company’s preliminary results.
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.