• Version
• Download 2917
• File Size 644.43 KB
• File Count 1
• Create Date February 9, 2022
• Last Updated August 25, 2025

Guidelines on submission of documentation for registration of Similar Biotherapeutic products

Introduction

Issued by the Pharmacy and Poisons Board (PPB), these guidelines provide a clear regulatory pathway for registering similar biotherapeutic products (SBPs), also known as biosimilars, in Kenya. Based on globally recognized standards, they ensure that SBPs are evaluated rigorously for quality, safety, and efficacy while leveraging existing data from reference biologics.

Scope

This Guideline Covers SBPs intended to replicate originator biotherapeutic products; including recombinant proteins, monoclonal antibodies, and other advanced biologics by demonstrating high similarity to reference products.

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.

Objectives

• Enable affordable access to essential biotherapeutics through simplified yet robust regulatory oversight Standardize documentation and evaluation processes for SBPs
• Promote alignment with international best practices (e.g., WHO guidelines) to maintain public health safeguards

Main Content

This guideline specifies the requirements for structuring applicationsFor registration of Similar Biotherapeutics Products. Applicants must demonstrate similarity between the product and the reference biotherapeutic in terms of structure, function, non-clinical, and clinical data. Each similar biotherapeutic product (SBP) is evaluated on an individual basis, with a strong emphasis on ongoing post-market safety monitoring.

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

Attached Files