- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
The Top 5 Biosimilar Articles for the Week of September 20
Here are the top 5 biosimilar articles for the week of September 20, 2021.
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 September 20, 2021.
Number 5: Investigators in China reported positive equivalence findings from a phase 3 trial of a bevacizumab biosimilar candidate (MIL60) and platinum-based chemotherapy as first-line treatment in Chinese patients with recurrent or advanced non–small cell lung cancer (NSCLC).
Number 4: A phase 3 study of a trastuzumab biosimilar candidate and the reference product (Herceptin) has demonstrated equivalence in patients with human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer, according to findings presented at the European Society for Medical Oncology (ESMO) Congress 2021.
Number 3: Alvotech gained an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; and BioFactura looks to deliver ustekinumab via a robotic pill.
Number 2: Alvotech said the FDA review of its high concentration, citrate-free adalimumab biosimilar candidate (AVT02) is held up by pandemic-related curbs on overseas inspections.
Number 1: The FDA has approved the first ranibizumab biosimilar (Byooviz, SB11) for multiple ophthalmologic conditions, although market launch is at least 9 months away, owing to patent protections on the originator product.
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.
