GaBI - Generics and Biosimilars Initiative

05/12/2025

ANVISA approves biosimilars for denosumab, trastuzumab, and aflibercept
https://gabionline.net/biosimilars/news/anvisa-approves-biosimilars-for-denosumab-trastuzumab-and-aflibercept

03/12/2025

Official Gazette of the Federation (DOF): ACUERDO por el que se modifica el artículo segundo del diverso que determina el tipo de prueba para demostrar intercambiabilidad de medicamentos genéricos / DOF: AGREEMENT modifying Article Two of the agreement that determines the type of test to demonstrate interchangeability of generic medicines and defines the criteria that must be applied to them
https://www.gob.mx/cms/uploads/attachment/file/1025561/2025.09.26_DOF_INTERCAMBIABILIDAD.pdf

01/12/2025

The International Conference on Harmonisation (ICH) has recommended regulatory bodies of ICH regions adopt the final draft of the M14 Guideline, which aids sponsors with the post-marketing safety requirements for regulatory submissions.

28/11/2025

WHO adds cancer and diabetes drugs to its essential medicines list

26/11/2025

Qualidade dos medicamentos genéricos no Brasil – Revisão / Quality of generic drugs in Brazil – Review

25/11/2025

EU steps closer to the ‘tailored approach’ for biosimilars development
https://gabionline.net/reports/eu-steps-closer-to-the-tailored-approach-for-biosimilars-development

19/11/2025

Rwanda FDA sets new price controls on medical drugs

Private pharmacies in Rwanda will now operate under a fixed markup ceiling of 33.5 per cent, following the release of new pharmaceutical pricing guidelines by the Rwanda Food and...

17/11/2025

How Europe can harness the full potential of biosimilars

Biosimilars - clinically equivalent alternatives to original biologic drugs - play a vital role in addressing the unmet health needs of European citizens and reducing the financial strain on healthcare services.

14/11/2025

ISP fortalecerá regulación de Dispositivos Médicos en Chile mediante financiamiento de CORFO / ISP will strengthen regulation of medical devices in Chile through CORFO funding

El Instituto de Salud Pública de Chile (ISP) se adjudicó fondos de CORFO por un total de $2.500 millones para implementar el proyecto “Fortalecimiento del Instituto de Salud Pública de Chile (ISP) para la Regulación de Dispositivos Médicos (DM)”, un hito que permitirá implementar un plan e...

13/11/2025

EMA recommends approval for nine biosimilars
https://gabionline.net/biosimilars/news/ema-recommends-approval-for-nine-biosimilars

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