GaBI - Generics and Biosimilars Initiative

10/11/2025

WuXi Biologics' Ireland site gets EMA nod

Dundalk, Ireland, August 18, 2025 — WuXi Biologics (Stock code: 2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that its Dundalk, Ireland facility has been approved by the European Medicines Agency (EMA) as a commercial manufacturin...

07/11/2025

Navigating the Path to Equitable Access to Trastuzumab in Middle-Income Countries: A qualitative analysis in South Africa and India

05/11/2025

NHS outlines streamlined drug review process

More details have emerged of a UK plan for new medicines to get simultaneous decisions from the MHRA and NICE on their use by the NHS.

03/11/2025

Patentes y costos alejan fármaco que previene el VIH de Latinoamérica
Patents and costs keep HIV prevention drug out of Latin America

Ciudad de México, 20 oct (EFE).- El lenacapavir podría prevenir hasta 84.000 infecciones de VIH en América Latina para 2030, según estimaciones del Instituto Nacional de Salud Pública (INSP) de México, pero su acceso sigue bloqueado por licencias privadas, precios inaccesibles y vacíos regula...

31/10/2025

UK government publishes guidance on the licensing of biosimilars

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29/10/2025

GaBI Journal, Volume 14, 2025, Issue 1, Now Available
https://gabi-journal.net/

28/10/2025

GaBI Journal, Volume 14, 2025, Issue 1, Now Available -

Manuscripts on all aspects of generic and biosimilar medicines covering areas in clinical, fundamental, technical, manufacturing, bioprocessing, economic and social aspects of pharmaceuticals and therapeutics are welcome. In addition, high quality work submitted in other formats, for example, scien...

27/10/2025

EMA plans guidance on external controls for evidence

24/10/2025

FDA, NIH create common vocabulary for real-world evidence

This article defines clinical research terms for study designs using real-world data to investigate regulated medical products and broader research.

22/10/2025

New guidance for biologicals in Pakistan and Hong Kong’s independent drug regulatory authority

In July 2025, the Drug Regulatory Authority of Pakistan (DRAP) published guidance on the requirement for clinical trials or biosimilarity studies t...

20/10/2025

FDA approves six denosumab biosimilars
https://gabionline.net/biosimilars/news/fda-approves-six-denosumab-biosimilars

17/10/2025

Avances en la regulación de productos biológicos en Argentina: del registro a la armonización global

La ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) de Argentina aplica un marco regulatorio sólido para los...