Module 9 2024

05/09/2024

What is Biosimilarity?

Posology and route of administration same

The route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product

Deviations as regards strength, pharmaceutical form, formulation, excipients or presentation require justification

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The Organisation for Professionals in Regulatory Affairs

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Legal Basis for Biosimilarity

375 Words in EU Directives

7311 Words in US Act

in US

Section 351 of the Public Health Service Act (42 U.S.C. 262) amended by The Biological, Price Competition & Innovation Act of 2009

Amendment Directive Dir. 2004/27/EC 30/10/05 Biosimilar legal concept 108 Words

Annex I Directive 2003/63/EC Biosimilar data requirements 267 words

The Organisation for Professionals in Regulatory Affairs

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