- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Top 5 Biosimilar Articles for the Week of July 4
Here are the top 5 biosimilar articles for the week of July 4, 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 July 4, 2022.
Number 5: During its annual conference in Sitges, Spain, Medicines for Europe recommended policy reforms for strengthening European health systems, including the use of off-patent medications like biosimilar and generic drugs.
Number 4: So far in 2022, the United States has taken some big steps in increasing biosimilar access and adoption throughout the nation, including 3 FDA approvals, an investigation into pharmacy benefit managers, and progress on congressional action.
Number 3: In the first human study of Shanghai Henlius Biotech's pertuzumab biosimilar candidate (HLX11), investigators found similar pharmacokinetic (PK), safety, and immunogenicity profiles between the biosimilar and the reference product (Perjeta).
Number 2: June brought with it several updates for biosimilars and the companies that make them, including the US launch of the first ranibizumab biosimilar, a new partnership between Organon and Shanghai Henlius Biotech, and the announcement of Sandoz’ global biosimilar initiative.
Number 1: Shanghai Henlius Biotech announced the commencement of a phase 3 trial for its denosumab biosimilar (HLX14) referencing Xgeva in postmenopausal patients with osteoporosis with a high risk of fracture.
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.
