GaBI - Generics and Biosimilars Initiative

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.

18/02/2026

FDA approves first generic estradiol vaginal insert for treatment of moderate to severe dyspareunia

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16/02/2026

EU releases guidance on breakthrough device criteria

China to cut import tariffs on medical devices
13/02/2026

China to cut import tariffs on medical devices

China will apply provisional import tariff rates lower than the most-favored-nation rates on 935 items from Jan. 1, 2026, the Customs Tariff Commission of the State Council announced on Monday.

Les biosimilaires font baisser les prix de l’insuline dans 28 pays européens
11/02/2026

Les biosimilaires font baisser les prix de l’insuline dans 28 pays européens

Une récente étude internationale (Italie, Suisse, Pays-Bas) analyse l’évolution des prix de l’insuline glargine dans 28 pays européens, sur la période 2013-2023, et le rôle de l’introduction des biosimilaires dans ces évolutions. Faisant apparaître d’intéressantes variations d’un ...

FDA publishes its Generic Competition and Drug Prices Report
04/02/2026

FDA publishes its Generic Competition and Drug Prices Report

FDA report describing the impact of competition on generic drug prices.

Role of biosimilar introduction on insulin glargine prices: a retrospective analysis in 28 European countries
02/02/2026

Role of biosimilar introduction on insulin glargine prices: a retrospective analysis in 28 European countries

Objective Quantify insulin glargine prices following the market introduction of biosimilars. Examine price levels and price changes for originator and biosimilars, by country. Methods Retrospective quantitative analysis using insulin glargine pricing data, both of the originator product and its bios...

28/01/2026

FDA may change user fee structure to favor US drug development

FDA will consider drugs after one trial instead of two
23/01/2026

FDA will consider drugs after one trial instead of two

The Food and Drug Administration plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval, FDA Commissioner Marty Makary told STAT on Wednesday. While historically the FDA has required two trials for added assurance of a drug’...

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