Nigeria - 2012 - Health

Biosimilar Guidance Document (NAFDAC)

Ministry of Health, National Agency for Food and Drug Administration and Control, Nigeria

The intention of this document is to provide acceptable principles for the registration of biosimilar products that are claimed to be similar to RBP of assured quality, safety, and efficacy that have been licensed based on a full registration dossier by a stringent regulatory authority. On the basis of proven similarity, the registration of a biosimilar will rely, in part, on non-clinical and clinical data generated with an already licensed RBP.

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Biosimilar Guidance Document (NAFDAC) Current Version

January 2022

The intention of this document is to provide acceptable principles for the registration of biosimilar products that are claimed to be similar to RBP of assured quality, safety, and efficacy that have been licensed based on a full registration dossier by a stringent regulatory authority. On the basis of proven similarity, the registration of a biosimilar will rely, in part, on non-clinical and clinical data generated with an already licensed RBP.

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