EMA – The Q&A on the tailored scientific advice to support step-by-step development of new biosimilars has been updated
Year: 2024
Type: other
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 ...
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12j9f
Author: Vroby
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: green
OpenAlex ID: W6974089923
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