Here are the top 5 biosimilar articles for the week of March 14, 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 March 14, 2022.
Number 5: Europe’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for 2 insulin biosimilars, meaning that the agency has recommended the European Commission grant them marketing authorization.
Number 4: Health Canada has approved Byooviz, a biosimilar referencing Lucentis (ranibizumab), for the treatment for several ophthalmic conditions. Byooviz represents the first ranibizumab biosimilar to be approved for the Canadian market.
Number 3: Teva Pharmaceuticals launched lenalidomide capsules, the generic of Revlimid, in the United States. The capsules are available in 5 mg, 10 mg, 15 mg, and 25 mg strengths, according to a statement from the company.
Number 2: AbbVie settled outstanding lawsuits, including its case related to the International Trade Commission (ITC), with Alvotech, giving Alvotech the green light to launch its high-concentration, citrate-free adalimumab biosimilar referencing Humira in July 2023, pending FDA approval.
Number 1: At a session at the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit, panelists suggested that the quest for rebates by pharmacy benefit managers (PBMs) prevents uptake on some biosimilars—and could soon bleed over into biosimilar formulary placement.
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.