GaBI - Generics and Biosimilars Initiative

GaBI - Generics and Biosimilars Initiative GaBI's mission - Building trust in cost-effective treatments

GaBI Online is a one-stop portal for global news on the recent developments in the field of generics and biosimilars, a repository of worldwide guidelines and an archive of related scientific information. GaBI Journal (official Journal of the Generics and Biosimilars Initiative) is an independent and peer reviewed academic Journal - encompasses all aspects of generic and biosimilar medicines development and use, from fundamental research to clinical application and policies.

EMA adopts landmark reflection paper on tailored clinical approach for biosimilars
08/04/2026

EMA adopts landmark reflection paper on tailored clinical approach for biosimilars

The European Medicines Agency (EMA) has formally adopted a landmark reflection paper that is set to streamline the development and approval of bios...

Congress Passes Landmark PBM Reform
01/04/2026

Congress Passes Landmark PBM Reform

Summary of H.R.4317 - 119th Congress (2025-2026): PBM Reform Act of 2025

EC outlines proposed reforms to medical device rules
31/03/2026

EC outlines proposed reforms to medical device rules

The EU revised the laws governing medical devices and in vitro diagnostics to align with the developments of the sector over the last 20 years.

FDA approves filgrastim biosimilar Filkri
25/03/2026

FDA approves filgrastim biosimilar Filkri

On 15 January 2026, the US Food and Drug Administration (FDA) approved the first biosimilar of the year, Accord Biopharma’s Filkr...

EC approves golimumab biosimilar Gotenfia and ranibizumab biosimilar Ranluspec
18/03/2026

EC approves golimumab biosimilar Gotenfia and ranibizumab biosimilar Ranluspec

On 10 February 2026, the European Commission (EC) granted marketing authorization for two biosimilars: Bio-Thera/Stada’s Gotenfia (golimumab); and...

OECD study finds no direct link between advertising rules and biosimilar uptake
16/03/2026

OECD study finds no direct link between advertising rules and biosimilar uptake

In December 2025, the Organisation for Economic Co-operation and Development (OECD) published a working paper titled ‘Assessing t...

SBR issues position statement on safe originator biological/biosimilar interchangeability
13/03/2026

SBR issues position statement on safe originator biological/biosimilar interchangeability

In early 2026, the Biotechnology Committee of the Brazilian Society of Rheumatology published a position statement on ‘the interchangeabil...

09/03/2026

Stop the "Genericization" of Biosimilars

China updates regulations to encourage research and innovation and improved drug safety
06/03/2026

China updates regulations to encourage research and innovation and improved drug safety

On 31 December 2025, China’s State Council announced a revision of Regulation for the Implementation of the Drug Administration Law, which is expec...

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