Module 9 2021

22/03/2021

DIFFERENT DEFINITIONS FOR BIOSIMILARITY?

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

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)

MEAN THE SAME

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WHAT IS BIOSIMILARITY?

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

Posology and route of administration same

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

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