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.

22/04/2026

ICH adopts M15 guideline to streamline drug development

FDA Monoclonal Antibody Testing Guidance faces industry scrutiny
20/04/2026

FDA Monoclonal Antibody Testing Guidance faces industry scrutiny

In December 2025, the US Food and Drug Administration (FDA) announced the availability of a draft guidance for industry...

EMA recommends approval of three new biosimilars for diabetes and autoimmune conditions
17/04/2026

EMA recommends approval of three new biosimilars for diabetes and autoimmune conditions

Bysumlog (insulin lispro), Dazparda (insulin aspart), and Fubelv (etanercept) receive positive CHMP opinionsOn 26 February 2026, the European Medic...

Biosimilar aflibercept (AVT06) pre-filled syringe promises safer, faster eye injections
16/04/2026

Biosimilar aflibercept (AVT06) pre-filled syringe promises safer, faster eye injections

For millions of people at risk of losing their sight, regular eye injections are a crucial but demanding part of treatment. A new study [1] shows t...

La EMA adopta un documento de reflexión histórico sobre el enfoque clínico adaptado para biosimilares
13/04/2026

La EMA adopta un documento de reflexión histórico sobre el enfoque clínico adaptado para biosimilares

La Agencia Europea de Medicamentos (EMA) ha adoptado formalmente un documento de reflexión innovador que tiene como objetivo optimizar el desarroll...

EMA recommends approval for pertuzumab and tocilizumab biosimilars
10/04/2026

EMA recommends approval for pertuzumab and tocilizumab biosimilars

On 26 February 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions positive...

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...

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