GaBI - Generics and Biosimilars Initiative

20/06/2025

EC approves three biosimilars, 14 more await final authorization
https://gabionline.net/biosimilars/news/ec-approves-three-biosimilars-14-more-await-final-authorization

18/06/2025

FDA, Japan's PMDA strengthen ties to accelerate regulation processes

MANILA – The Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) met on Tuesday to optimize the facilitated review pathway (FRP) to expedite access to essential medicines and medical devices. In a news release on Wednesday, the FDA said the meeting…

16/06/2025

Students develop plant-based semaglutide production

Their breakthrough could one day let you grow lifesaving drugs in your backyard.

13/06/2025

Alcanzar los objetivos ASG en el desarrollo farmacéutico

Un artículo reciente publicado en la revista GaBI Journal, titulado ‘Alineación de los criterios ambientales, sociales y de gober...

11/06/2025

Reaching ESG goals in pharmaceutical development

A recent article published in GaBI Journal, ‘Aligning environmental, social, and governance to clinical development: moving towards more sustainabl...

04/06/2025

Evaluating biosimilars: safety, efficacy, and regulatory considerations in clinical studies
https://link.springer.com/article/10.1007/s11096-024-01825-8

02/06/2025

WHO members approve pandemic preparedness agreement

World Health Organization Member States, meeting today in Committee A of the World Health Assembly, approved a resolution that calls for the adoption of an historic global compact to make the world safer from future pandemics. The WHO Pandemic Agreement will next be considered for final adoption by...

30/05/2025

EMA recommends approval for three denosumab biosimilars: Bomyntra, Conexxence, and Rolcya

On 23 May 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions reco...

28/05/2025

Biosimilar clinical efficacy studies: are they still necessary?

A paper published in Drugs, explores the evolution in biosimilars regulatory thinking which is now moving away from the default requiremen...

26/05/2025

China-to-West pharma licensing deals surge in 2024 amid innovation push

A recent analysis of 48 pharmaceutical licensing deals from Chinese to Western companies in 2024 reveals a surge worth U...

23/05/2025

FDA approves bevacizumab biosimilar Jobevne

On 9 April 2025, the US Food and Drug Administration (FDA) has approved Biocon’s Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab refe...

21/05/2025

Pharma firms urge UK to revise drug cost controls: Delivering a voluntary scheme for health and growth
https://www.abpi.org.uk/media/t4ih3u0o/abpi-vpag-report-20-march-2025.pdf