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.

FDA approves third interchangeable insulin glargine biosimilar Langlara
10/06/2026

FDA approves third interchangeable insulin glargine biosimilar Langlara

On 30 April 2026, the US Food and Drug Administration (FDA) approved Sunshine Lake Pharma’ Langlara (insulin glargine-aldy) as an interchangeable b...

Amgen expansion, BioNTech retrenchment highlight diverging manufacturing strategies in biopharma
08/06/2026

Amgen expansion, BioNTech retrenchment highlight diverging manufacturing strategies in biopharma

The global biopharmaceutical manufacturing landscape is undergoing a significant realignment, as illustrated by two contrasting announcements&n...

Biosimilars uptake in Chile: why does it lags behind?
05/06/2026

Biosimilars uptake in Chile: why does it lags behind?

Exploring the barriers to biosimilar adoption in ChileIn Chile, biosimilars uptake is limited, especially for oncology b...

FDA guidance marks regulatory shift in statistical method
25/05/2026

FDA guidance marks regulatory shift in statistical method

This draft guidance provides guidance to sponsors and applicants on the appropriate use of Bayesian methods in clinical trials.

Out-of-Pocket Spending for Biologic Drugs After Biosimilar Competition for Medicare Patients
22/05/2026

Out-of-Pocket Spending for Biologic Drugs After Biosimilar Competition for Medicare Patients

This cross-sectional study found that biosimilar competition was associated with lower OOP spending for Medicare patients, likely because many patients paid a percentage of drug costs. These findings suggest that by reducing OOP spending, biosimilar competition can improve access and adherence to bi...

20/05/2026

FDA issues draft guidance for the use of AI to support regulatory decision-making for
drug and biological products

18/05/2026

EMA Network Data Steering Group Updates 2-Year Workplan

Adres

Postbus 10001
Mol
BE-2400

Telefoon

+32-474989572

Website

,

Meldingen

Wees de eerste die het weet en laat ons u een e-mail sturen wanneer GaBI - Generics and Biosimilars Initiative nieuws en promoties plaatst. Uw e-mailadres wordt niet voor andere doeleinden gebruikt en u kunt zich op elk gewenst moment afmelden.

Contact De Universiteit

Stuur een bericht naar GaBI - Generics and Biosimilars Initiative:

Snelkoppelingen

Delen