GaBI - Generics and Biosimilars Initiative

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This draft guidance provides guidance to sponsors and applicants on the appropriate use of Bayesian methods in clinical trials.

22/05/2026

Out-of-Pocket Spending for Biologic Drugs After Biosimilar Competition for Medicare Patients

This cross-sectional study found that biosimilar competition was associated with lower OOP spending for Medicare patients, likely because many patients paid a percentage of drug costs. These findings suggest that by reducing OOP spending, biosimilar competition can improve access and adherence to bi...

20/05/2026

FDA issues draft guidance for the use of AI to support regulatory decision-making for
drug and biological products

18/05/2026

EMA Network Data Steering Group Updates 2-Year Workplan

15/05/2026

Key oncology drugs gained FDA designations in early 2026

In January, the U.S. Food and Drug Administration granted designations to various treatments for lung, pancreatic, and blood cancers, among others. Here are some of the key highlights.

13/05/2026

EMA proposes extending reach of EudraLex Annex 15

11/05/2026

FDA set AI guidelines for drug development

10 guiding principles that industry and product developers can consider when using artificial intelligence (AI) to advance drug & biological product development

08/05/2026

UK issues draft guidance on changes to clinical trial law

Legal framework, regulatory requirements, and supporting guidance needed to design, apply for, conduct, modify, close, and comply with UK legislation for clinical trials for medicines in the UK.

06/05/2026

European Pharmacopoeia publishes first individual product monoclonal antibody monograph

The European Pharmacopoeia (Ph. Eur.) has published its first monoclonal antibody (mAb) medicinal product monograph for the IgG1-antibody based TNF...

04/05/2026

Costa Rica abre consulta sobre la reforma al registro y control de medicamentos biológicos

60 días sobre las reformas propuestas al Decreto Ejecutivo N.° 37006-S del 15 de noviembre de 2011 [1, 2], que establece el marco regulatorio para...