EMA – The Q&A on the tailored scientific advice to support step-by-step development of new biosimilars has been updated

The EMA updated its Questions and Answers on the tailored scientific advice to support step-by-step development of new biosimilars destined to biosimilar developpers. EMA offers tailored scientific advice on development programmes of new biosimiliar medicines. The tailored procedure advises developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available. More specifically, tailored scientific advice can help assess ...

Publication Details

Journal
Industrias Culturais (Universidade de Coimbra)
Published
2024-10-19
DOI
https://doi.org/10.58079/12j9f
Primary Topic
Biosimilars and Bioanalytical Methods
Type
article
Field-Weighted Citation Impact
0.00
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article

EMA – The Q&A on the tailored scientific advice to support step-by-step development of new biosimilars has been updated

Industrias Culturais (Universidade de Coimbra)
Biosimilars and Bioanalytical Methods
article

EMA – The Q&A on the tailored scientific advice to support step-by-step development of new biosimilars has been updated

article en

Abstract

The EMA updated its Questions and Answers on the tailored scientific advice to support step-by-step development of new biosimilars destined to biosimilar developpers. EMA offers tailored scientific advice on development programmes of new biosimiliar medicines. The tailored procedure advises developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available. More specifically, tailored scientific advice can help assess ...

Industrias Culturais (Universidade de Coimbra)
Industry, innovation and infrastructure
Openalex Percentile: Top 51%
Biosimilars and Bioanalytical Methods
DOIOpen Access PDFOpenAlex
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EMA – The Q&A on the tailored scientific advice to support step-by-step development of new biosimilars has been updated · Industrias Culturais (Universidade de Coimbra) (2024) | TGRS Research Map | TGRS