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.

El HHS equipara biosimilares a genéricos y desata rechazo
07/10/2026

El HHS equipara biosimilares a genéricos y desata rechazo

El Departamento de Salud y Servicios Humanos de EE. UU. (HHS), a través de la Administración de Alimentos y Medicamentos de EE. UU. (FDA), está pon...

ANVISA and DINAVISA sign MoU to strengthen border surveillance and regulatory cooperation
25/09/2026

ANVISA and DINAVISA sign MoU to strengthen border surveillance and regulatory cooperation

Brazil’s National Health Surveillance Agency (ANVISA) and Paraguay’s National Directorate of Health Surveillance (DINAVISA) signed a new Memorandum...

HHS push to ‘genericize’ biosimilars sparks backlash
23/09/2026

HHS push to ‘genericize’ biosimilars sparks backlash

The US Department of Health and Human Services (HHS), through the US Food and Drug Administration’s (F...

Canada approves multiple denosumab and ustekinumab biosimilars as global competition grows
17/09/2026

Canada approves multiple denosumab and ustekinumab biosimilars as global competition grows

Health Canada has approved several new biosimilars referencing Amgen’s Prolia/Xgeva (denosumab) and Janssen’s Stelara (ustekinumab) in the first ha...

Drug repurposing initiative may signal change in regulatory approach
11/09/2026

Drug repurposing initiative may signal change in regulatory approach

The U.S. Food and Drug Administration (FDA) recently launched a drug repurposing initiative that may signal a shift in how the Agency approaches...

WHO releases list of device regulators eligible for listed authority status
09/09/2026

WHO releases list of device regulators eligible for listed authority status

On 14 July 2026, the World Health Organization (WHO) published its first interim list of regulatory authorities for medical devices, known as transitional WHO Listed Authorities (tWLAs). The list marks an important milestone in strengthening global regulatory cooperation and supporting regulatory re...

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...

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