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.

26/09/2025

Report on a Collaborative Study for Proposed 1st WHO International Standard for Ranibizumab

EMA approves two new macitenan generics
24/09/2025

EMA approves two new macitenan generics

13 new medicines recommended for approval; another 8 medicines recommended for extension of their therapeutic indications

AI tools tackle shape-shifting proteins
22/09/2025

AI tools tackle shape-shifting proteins

Intrinsically disordered proteins have been historically difficult to target

19/09/2025

Proposed WHO International Biological Reference Preparations for Adalimumab anti-drug antibodies

Congress should remove the rare disease carve-out from Medicare drug price negotiation, not expand it
08/09/2025

Congress should remove the rare disease carve-out from Medicare drug price negotiation, not expand it

Expansion of the Medicare drug price negotiation rare disease drug carve-out would unnecessarily limit the number of drugs eligible for negotiation, allow for continued high drug prices for products that earn billions of dollars in Medicare, and introduce a new set of misaligned incentives.

EU guidance clarifies AI compliance under MDR, IVDR
05/09/2025

EU guidance clarifies AI compliance under MDR, IVDR

MDCG 2025-6 - FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) (June 2025)

Study notes disparities in new drugs approved in the US and Japan
03/09/2025

Study notes disparities in new drugs approved in the US and Japan

This cross-sectional study evaluates drug approval disparities between the US and Japan from 2005 to 2022.

01/09/2025

GMP/GDP Inspectors Working Group (GMP/GDP IWG) Concept paper on the revision of Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products)

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