Guidelines on submission of documentation for registration of Similar Biotherapeutic products

This Guideline is made to provide guidance to applicants on the procedure for registering a Similar Biotherapeutic Product in Kenya. The guideline applies to well-established and well-characterized biotherapeutic products such as recombinant DNA-derived therapeutic proteins. Vaccines and plasma derived products and their recombinant analogues are excluded from the scope of these guidelines.

This document is intended to provide guidance on issues to consider when demonstrating that a proposed biological product is similar to, a reference biotherapeutic product already registered, well established for purposes of submitting a marketing application.For the purpose of this document, a Similar Biotherapeutic Product (a short designation for highly similar biological medicinal product) is considered as a new biological medicinal product developed to be similar in terms of quality, safety and efficacy to an already registered, well established, medicinal product.

This guideline should be read in conjunction with the Guideline for the Registration of Biotherapeutic products.