GaBI - Generics and Biosimilars Initiative

26/03/2025

IFPMA publica su posición sobre la sustitución de biosimilares mediada por farmacias

En enero de 2025, la Federación Internacional de Asociaciones de Fabricantes y Productores Farmacéuticos (International Federation of Phar...

24/03/2025

Canada approves pegfilgrastim biosimilar Pexegra

On 25 February 2025, Health Canada granted marketing authorization to India-based Kashiv BioSciences for its pegfilgrastim biosimilar, Pex...

21/03/2025

Reflection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs

19/03/2025

ISMP stresses drug label standardization

A new review of all 50 state boards of pharmacy regulations by the ISMP has shown that only one or two boards provided detailed guidance for pharmacy drug labeling, ...

17/03/2025

Insulin aspart and denosumab biosimilars approved in US

In February 2025, the US Food and Drug Administration (FDA) approved Sanofi-Aventis’ Merilog (insulin aspart-szjj), refe...

14/03/2025

IMDRF finalizes good machine learning practice, software risk documents
Good machine learning practice for medical device development: Guiding principles

Good machine learning practice for medical device development: Guiding principles

12/03/2025

Manufacturers submit different data to FDA, EMA for cell and gene therapies

This cross-sectional study compares how sponsors approach parallel submissions of gene and cell therapy applications to drug regulatory agencies.

10/03/2025

Importing generics could ease US drug shortages

Two-thirds of generic sterile injectable drugs in shortage could be imported from well-regulated foreign markets

07/03/2025

EMA adopts guideline on requirements for clinical-stage ATMPs

06/03/2025

Biosimilars in low- and middle-income countries

Biosimilars offer a viable route to treatment for those with non-communicable diseases (NCDs) living in low- and middle-income countries (LMICs). A...

03/03/2025

Lawsuit accuses agencies of unlawfully removing health data

The Trump administration recently removed heath data from government websites, which spurred a federal lawsuit filed Tuesday by the Doctors for America organization.

28/02/2025

Global regulators advance IDMP implementation

NORTH BETHESDA, MD @ Regulators around the globe are making progress in implementing the Identification of Medicinal Products (IDMP) a global set of standards for identifying medicinal products. The EU is at the forefront of these efforts, while other countries, including Switzerland and Canada, are...

26/02/2025

FDA issues guidance on AI use in drug and biologicals regulatory decision making
https://gabionline.net/guidelines/fda-issues-guidance-on-ai-use-in-drug-and-biologicals-regulatory-decision-making

24/02/2025

Characterization Considerations for Medical Device Software and Software-Specific Risk

21/02/2025

Estratégia para o lançamento de um produto inovador na indústria farmacêutica brasileira. O caso de um medicamento para tratamento de Covid-19

Estratégia para o lançamento de um produto inovador na indústria farmacêutica brasileira O caso de um medicamento para tratamento de Covid-19 Autores Ligia Maura Primo Maluf UNIVERSIDADE PRESBITERIANA MACKENZIE Adilson Caldeira Universidade Presbiteriana Mackenzie Reynaldo Cavalheiro Marcondes U...

19/02/2025

Indonesia works toward pharmaceutical independence

Indonesia's Health Ministry is expediting efforts to achieve domestic pharmaceutical independence to address the evolving needs of the national health ...

19/02/2025

EC approves eight biosimilars, eight more await final authorization

The European Commission (EC) granted marketing authorization for seven biosimilars: Sandoz’s Afqlir, Formycon’s Ahzantive/Baiama,...

17/02/2025

Efeitos da entrada de genéricos no mercado sobre os preços de medicamentos