GaBI Generics and Biosimilars Initiative

Generics and biosimilar Initiative

Building trust in cost-effective treatments

eng/ esp

GMP certification requirements in Argentina, Brazil and Mexico

Reports/ | Posted 17/09/2021 0

138 AA011155

Marketing authorisation (MA) of a medicinal product is the process of reviewing and assessing the evidence to support that product, in relation to its marketing, finalized by granting of a licence...

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LATIN AMERICAN FORUM

Knowledge and perceptions of naming for biosimilars in the US

Posted 10/09/2021

Naming 1 V13I27

The relatively recent introduction of biosimilars to the US market and the new naming c...

GABiC proposes the use of biosimilars as strategy for innovation and sustainability

Posted 10/09/2021

The commitment to biosimilars as a strategy to promote innovation and sustainability is...

Mexico introduces new decree on health regulation

Posted 27/08/2021

Regulation-V13H16

On 31 May 2021, COFEPRIS published the Decree which specifies changes to the Health Sup...

Naming 1 V13I27

Knowledge and perceptions of naming for biosimilars in the US

Posted 10/09/2021

The relatively recent introduction of biosimilars to the US market and the new naming c...

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GABiC proposes the use of biosimilars as strategy for innovation and sustainability

Posted 10/09/2021

The commitment to biosimilars as a strategy to promote innovation and sustainability is...

Regulation-V13H16

Mexico introduces new decree on health regulation

Posted 27/08/2021

On 31 May 2021, COFEPRIS published the Decree which specifies changes to the Health Sup...

Home/Non‐Biological Complex Drugs

Liposome V15L11

FDA issues final guidance on liposome drug products

Posted 27/04/2018 0

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance...

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Generics

Generic pharmaceutical policies in the MENA region

Generics/Research | Posted 17/09/2021

Sandoz launches ferumoxytol and pemetrexed generics

Generics/News | Posted 03/09/2021

Generics applications under review by EMA – July 2021

Generics/General | Posted 23/07/2021

The generics market in Brazil

Generics/Research | Posted 16/07/2021

Biosimilars

Bevacizumab biosimilars launched in Spain and Korea

Biosimilars/News | Posted 17/09/2021

Off-patent biologicals/Biomimics approved in Bolivia

Biosimilars/General | Posted 17/09/2021

Clinical pharmacists have a critical role in increasing biosimilar uptake

Biosimilars/Research | Posted 17/09/2021

Clinical development of biosimilars in the oncology setting

Biosimilars/Research | Posted 17/09/2021