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.

Congress pushes biosimilar bills as interchangeability concerns linger
07/09/2026

Congress pushes biosimilar bills as interchangeability concerns linger

US Congress is fast‑tracking multiple biosimilar bills this summer, but a new analysis warns that eliminating interchangeability requireme...

NIBRT designated as WHO regional training centre for biomanufacturing in the European region
28/08/2026

NIBRT designated as WHO regional training centre for biomanufacturing in the European region

PRESS RELEASE NIBRT has been designated by WHO as the Regional Training…

La ANVISA de Brasil actualiza las directrices sobre los estudios farmacocinéticos de los biosimilares
26/08/2026

La ANVISA de Brasil actualiza las directrices sobre los estudios farmacocinéticos de los biosimilares

La Agencia Nacional de Vigilancia Sanitaria de Brasil (ANVISA) publicó el 29 de junio de 2026 la Nota Informativa 1/2026/GGBIO, que ofrece aclaraci...

EMA recommends approval for biosimilar pegfilgrastim Cavoley
24/08/2026

EMA recommends approval for biosimilar pegfilgrastim Cavoley

On 23 July 2026, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommendi...

Brazil's ANVISA updates guidance on pharmacokinetic studies for biosimilars
21/08/2026

Brazil's ANVISA updates guidance on pharmacokinetic studies for biosimilars

The Brazilian Health Regulatory Agency (ANVISA) published on 29 June 2026, Informative Note 1/2026/GGBIO, providing clarifications on the evaluatio...

Malaysia, Thailand implement medical device reliance program after successful pilot
19/08/2026

Malaysia, Thailand implement medical device reliance program after successful pilot

Official portal of MDA Malaysia. Regulatory information, device registration & safety under Medical Device Acts 737 & 738

14/08/2026

EU sets uniform quality rules for conformity assessments

US Food and Drug Administration competitive generic therapy approvals and drug competition
12/08/2026

US Food and Drug Administration competitive generic therapy approvals and drug competition

US Food and Drug Administration Competitive Generic Therapy Approvals and Drug Competition

10/08/2026

El mercado de medicamentos genéricos en EcuadorThe generic drug market in Ecuador

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