GaBI - Generics and Biosimilars Initiative

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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.

09/01/2026

EMA approves teduglutide generic

Ten new medicines recommended for approval; another four medicines recommended for extension of their therapeutic indications

07/01/2026

FDA approves denosumab biosimilars Osvyrti and Jubereq, Boncresa and Oziltus
https://gabionline.net/biosimilars/news/fda-approves-denosumab-biosimilars-osvyrti-and-jubereq-boncresa-and-oziltus

06/01/2026

Biosimilar Ranibizumab (Ranieyes) Safety and Efficacy in the Real World: BRESER Study
https://pubmed.ncbi.nlm.nih.gov/40028177/

29/12/2025

EMA approves rivaroxaban generic Rivaroxaban Koanaa

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

26/12/2025

Mechanisms influencing generic drug substitution behaviour under the national centralized drug procurement policy

This study highlights the importance of enhancing physicians' positive attitudes towards bid-winning generics, fostering a supportive normative environment, and mitigating excessive perceived behavioral control. These strategies may strengthen prescribing intentions, support effective and sustainabl...

22/12/2025

STADA Expands Specialty Biosimilars Portfolio through European Approval for Afiveg (aflibercept)
https://www.stada.com/blog/posts/2025/september/stada-expands-specialty-biosimilars-portfolio-through-european-approval-for-afiveg-aflibercept

19/12/2025

The MAHA Strategy

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...

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http://gabionline.net/, http://gabi-journal.net/

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