Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Paul Johns
Trade Marks

CHMP Recommends Marketing Approval for Sandoz’s Bevacizumab Biosimilar

May 30, 2024

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of marketing authorisation for FGK’s Avzivi®, biosimilar to Genentech’s Avastin® (bevacizumab).   

The applicant for Avzivi in the EU is FGK Representative Service GmbH, which provides legal representative services to sponsor companies not based in the EU.  However, Bio-Thera is the developer of the product, which is to be marketed by Sandoz (including in the EU) pursuant to a licence and commercialisation agreement entered between Bio-Thera and Sandoz in September 2021. 

Avzivi® was FDA approved in December 2023.