Module 9 2024

05/09/2024

Different Definitions for Biosimilarity

Highly similar

Similarity in terms of quality, biological activity, safety and efficacy based on comprehensive comparability exercise Similar, in molecular and biological terms (amino acid sequence same)

Notwithstanding minor differences in clinically inactive components No clinically meaningful differences in terms of the safety, purity, and potency (amino acid sequence same)

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The Organisation for Professionals in Regulatory Affairs

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Different Definitions for Biosimilarity

INCLUDES , All recombinant peptides

EXCLUDES

Synthetic peptides ≤ 100 amino acids, Recombinant peptides ≤ 40 and

LMW heparin

EXCLUDES

non proteins LMW heparin

Synthetic peptides

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The Organisation for Professionals in Regulatory Affairs

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