GaBI - Generics and Biosimilars Initiative

17/12/2025

Questions and answers for biological medicinal products

Questions and answers for biological medicinal products HumanBiologicalsRegulatory and procedural guidanceResearch and developmentScientific guidelines

15/12/2025

Belgium to fight cancer with radioligand therapy boom by 2027

Belgium will modernise infrastructure, streamline reimbursement and ensure timely patient access to next-gen radioactive isotope cancer treatments

12/12/2025

ANVISA launches new digital form for international users

New tool facilitates access to the Agency's information.

11/12/2025

Adalimumab around the world: comparative analysis of products characteristics and patient support systems
https://pmc.ncbi.nlm.nih.gov/articles/PMC12497974/

08/12/2025

ANVISA aprueba cuatro biosimilares para denosumab, trastuzumab y aflibercept

En Septiembre de 2025, ANVISA, la Agência Nacional de Vigilância Sanitária de Brasil, emitió dictámenes favorables en los que rec...

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...