Establishing bioequivalence capacity in Kenya: Feasibility insights,strategic pathways,and regulatory imperatives

Abstract

Background

Bioequivalence (BE) studies are crucial for ensuring generic medicines meet the same rigorous standards of quality, safety, and efficacy as their corresponding innovator brands. Since 2010, locally manufactured multisource drug products have been exempted from BE requirements for registration in Kenya, creating a regulatory gap that undermines medicine quality assurance and poses a major hurdle to the attainment of Maturity Level 3 certification by the World Health Organization.

Objective

This study assessed Kenya’s readiness to implement mandatory BE requirements in medical product registration, focusing on the adequacy of human capital, infrastructural capacity, regulatory alignment with global best practices, and demand forecasting for BE services.

Methods

A multimodal study design was employed. The study, conducted between May and July 2024, encompassed stakeholder engagements, facility assessments, and a literature review of regional and global best practices in BE implementation. Potential demand for BE services and risk-based product prioritization were also integrated. Data was collected through structured questionnaires, in-depth questionnaires, key informant interviews, and desktop literature review. The data was analyzed in Microsoft Excel version 2024 and summarized as frequencies, percentages, means and medians as appropriate.

Results

Stakeholders overwhelmingly supported BE enforcement as a public health imperative, but cited infrastructure gaps, cost, and ambiguity in regulatory directives as major challenges. Key recommendations included phased BE implementation, risk-based product prioritization, public-private partnerships, adoption of a modular BE service provision, and financial incentives for local manufacturers, including pilot studies for 20 priority products.

Conclusion

Kenya’s transition toward a functional BE system is feasible but requires strategic investment, regulatory refinement, and capacity-building. This study provides actionable insights to guide policy, strengthen regulatory systems, and enhance access to quality-assured medicines.