Guidelines for the regulation of biologics, biosimilars and radiopharmaceuticals in Brazil

Guidelines/ | Posted 01/12/2022 comments 0
ANVISA V22A14

ANVISA (Agência Nacional de Vigilância Sanitária), the National Health Surveillance Agency of Brazil, published in November 2022 three new guidance documents on the regularization of biol...

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FORO LATINOAMERICANO DE ESTA SEMANA
02 AA010638
Nomenclature of biologicals and biosimilars in Peru
Posted 20/05/2022

This article, the last in a series on the nomenclature of biological and biosimilar med...

Brazil flag V13C03
Brazilian market of biosimilars
Posted 20/05/2022

As the largest country in South America, Brazil is an important market for the pharmace...

Guidance V13F21
WHO revised guidelines for biosimilars: scientific background
Posted 08/07/2022

A study carried out by Kurki P et al. in 2022 reviewed the current clinical experi...

Home/Non‐Biological Complex Drugs
Liposome V15L11

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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