Barriers to WHO prequalification of similar biotherapeutic insulin.

Objective: To identify the barriers preventing manufacturers of similar biotherapeutic human insulin from submitting their products to the World Health Organization (WHO) for prequalification.

Methods: We used a self-administered questionnaire to collect data from companies producing similar biotherapeutic human insulin. We included questions about the insulin products manufactured, knowledge of WHO prequalification requirements, export of the products and compliance with good manufacturing practices. Companies had the possibility to provide additional relevant information. We sent the questionnaire to 20 manufacturers in total. We evaluated responses and organized the data into themes.

Results: We had a response rate of 55% (11/20 companies). Five broad themes emerged: (i) manufacturers and products; (ii) expressions of interest awareness and participation; (iii) need for technical assistance and training; (iv) market and supply chain challenges; and (v) approval for good manufacturing practices. The most important reasons for manufacturers' lack of response to WHO's expression-of-interest invitation were absence of a mechanism to guarantee return on investment, and perceived complexity of prequalification requirements for insulin-similar biotherapeutic products.

Conclusion: To encourage greater participation in the WHO prequalification programme, international procurement agencies associated with the programme should consider establishing a platform to enter into advance purchasing agreements with manufacturers. In addition, WHO's Local Production and Assistance Unit should provide companies with ongoing technical assistance on the development of their human insulin products and improvement of their production facilities to comply with the WHO requirements for good manufacturing practices.