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Investigating biosimilar product drift and divergence

Biosimilars/Research | Posted 25/11/2022 comments 0
T cell V21G23

Following the establishment of biosimilarity, there are no regulations that require manufacturers to perform quality or clinical studies to compare biosimilar versus originator products post-approv...

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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

FDA issues final guidance on liposome drug products

Posted 27/04/2018 comments 0

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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