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 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)

Hulio granted US interchangeability status
27/08/2025

Hulio granted US interchangeability status

In May 2025, the US Food and Drug Administration (FDA) announced the decision to grant interchangeability status to&...

NATO Innovation Fund makes first investments to secure the future of the Alliance’s 1 billion citizens
25/08/2025

NATO Innovation Fund makes first investments to secure the future of the Alliance’s 1 billion citizens

The NATO Innovation Fund announced today its first deep tech investments to address challenges in defence, security and resilience. These initial equity investments made by the €1 billion Fund will help advance innovation in novel materials and manufacturing, AI, space and robotics. The Fund is al...

Frequency of first generic drugs approved through ‘skinny labeling’, 2021 to 2023
22/08/2025

Frequency of first generic drugs approved through ‘skinny labeling’, 2021 to 2023

Previous literature found 43% of brand-name drugs experienced skinny labeling generic prescription competition in a 2015-2019 sample, which is consistent with the rate of skinny labeled generic prescription entry early in our sample. Then, the proportion of first generic prescriptions approved with....

EMA recommends approval of HIV and lung disease generics
20/08/2025

EMA recommends approval of HIV and lung disease generics

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

El ‘One Big Beautiful Bill’ de Trump: implicaciones para la sanidad estadounidense
18/08/2025

El ‘One Big Beautiful Bill’ de Trump: implicaciones para la sanidad estadounidense

El 4 de julio de 2025, el presidente de Estados Unidos, Donald Trump, promulgó un paquete de medidas fiscales y de gasto destinado a cumplir varias...

Trump’s ‘One Big Beautiful Bill’: implications for US health care
14/08/2025

Trump’s ‘One Big Beautiful Bill’: implications for US health care

On 4 July 2025, US President Donald Trump signed into law a tax and spending package designed to fulfil several of his electoral campaign promises....

11/08/2025

Generics, Biosimilars and Follow-­ On Non-­ Biologic Complex Drugs for Multiple Sclerosis: A Narrative Review of the Regulatory and Clinical Implications for European Neurologists

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