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.

19/06/2026

FDA consolidates adverse event reporting
https://www.fda.gov/news-events/press-announcements/fda-launches-new-adverse-event-look-tool

Mintz’s Managed Care, PBMs & Pharmacies practice is pleased to present a combined Summer / Fall 2025 PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from April through September that affects the PBM industry. It highlights federal legislative upda...

17/06/2026

WHO adopted the Recommendations for the preparation, characterization, establishment and
use of WHO international biological reference standards

15/06/2026

FDA issues draft guidance on exclusivity for new drugs
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers

New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers

12/06/2026

EMA recommends approval for ranibizumab biosimilar Vislyfa
https://gabionline.net/biosimilars/news/ema-recommends-approval-for-ranibizumab-biosimilar-vislyfa

10/06/2026

FDA approves third interchangeable insulin glargine biosimilar Langlara

On 30 April 2026, the US Food and Drug Administration (FDA) approved Sunshine Lake Pharma’ Langlara (insulin glargine-aldy) as an interchangeable b...

08/06/2026

Amgen expansion, BioNTech retrenchment highlight diverging manufacturing strategies in biopharma

The global biopharmaceutical manufacturing landscape is undergoing a significant realignment, as illustrated by two contrasting announcements&n...

05/06/2026

Biosimilars uptake in Chile: why does it lags behind?

Exploring the barriers to biosimilar adoption in ChileIn Chile, biosimilars uptake is limited, especially for oncology b...

03/06/2026

FDA OKs pembrolizumab plus paclitaxel for recurrent ovarian cancers
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-paclitaxel-platinum-resistant-epithelial-ovarian-fallopian-tube-or

01/06/2026

EMA recommends approval for ranibizumab biosimilar Rexatilux
https://gabionline.net/biosimilars/news/ema-recommends-approval-for-ranibizumab-biosimilar-rexatilux

25/05/2026

FDA guidance marks regulatory shift in statistical method

This draft guidance provides guidance to sponsors and applicants on the appropriate use of Bayesian methods in clinical trials.

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

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