GaBI - Generics and Biosimilars Initiative

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This draft guidance provides guidance to sponsors and applicants on the appropriate use of Bayesian methods in clinical trials.

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FDA issues draft guidance for the use of AI to support regulatory decision-making for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