The Utrecht Centre of Excellence for Affordable Biotherapeutics for Public Health (“UCAB”) is a non-profit foundation that aims to facilitate the development and sustainable production of high quality and affordable biotherapeutics in low and middle income countries (LIMCs) according to European standards. UCAB is the result of collaboration between Utrecht University and the World Health Organization.
Biopharmaceuticals have a huge impact on health care costs even in high income countries. The expiry of patents of biopharmaceuticals has been deployed several years ago and will continue. In contrast to patent expiration of small molecules, the production of a biopharmaceutical after patent expiration (biosimilar) will not provide a great financial advantage. The regulatory route to obtain market authorization for biosimilars requires still a great investment. Reduction of the costs for the development process to obtain market authorization for biosimilars may be a first step to further reduce the costs for biopharmaceuticals in LMICs. Experiences in the field of vaccines have shown that the production by local manufacturers in LMICs can additionally lead to considerable cost reductions as a second step.
In order to 1) share development costs and 2) facilitate local production, UCAB forms strategic business associations with local manufacturers and a lead manufacturer. By making use of the same producing clone, by using the same manufacturing process and organizing centralized quality control, the local manufacturer can refer to the central database, eliminating the need to repeat costly development procedures. This will facilitate the local manufacturer to produce biotherapeutics in a timely, cost-effective and high quality manner. UCAB coordinates the development of a central knowledge database containing regulatory requirements for local market authorization according to EU standards (which are acceptable for most LMICs). The costs and the use of the preparation of this central file for regulatory submission will be shared by the members of a consortium of local manufacturers, preceding the shared revenues.
The mission of UCAB is to improve global health by enabling the sustainable production of high quality and affordable biotherapeutics that are accessible to patients in low and middle income countries (LMICs).
- The development of biotherapeutics with the greatest impact on public health in LMICs and included in the Essential Medicine list by WHO.
- Adherence to all local and international standards during the entire development process.
- Aiming at the highest possible quality standards for the products.
- Analysis of the medical need in LMIC’s for biopharmaceuticals and subsequent the development of a strategy for reducing development costs in whatsoever construction to enable sustainable production of an affordable biopharmaceutical.
- The formation of business organizations comprising of a lead manufacturer and local manufacturers with the common aim of the affordable and sustainable production of a biotherapeutic in LIMCs by preparing a central file for local marketing authorization applications.
- Bringing together the product development expertise of the lead manufacturer and sharing clinical, regulatory and quality control activities by UCAB, a technical dossier will be compiled in a way that locally produced products meet the required standards for obtaining marketing authorization.
- The integration of the knowledge and experience of biopharmaceuticals within UCAB and the Utrecht University to contribute to global knowledge of biotherapeutics.
Palivizumab biosimilar: starting UCAB – WHO project
UCAB is currently working with an European lead manufacturer and three local manufacturers in LIMC’s on the development of a biosimilar of palivizumab, a preventive treatment against RSV (Respiratory Syncytial Virus) infection in children < two years of age. RSV infection is the second most important cause of death during infancy, especially in developing countries. Palivizumab is marketed under the brand name Synagis®, and a treatment course costs ± $ 9600,- in the US. According to the head of the Technology Transfer Team at the World Health Organization (WHO) in Geneva, a biosimilar version of palivizumab could be produced for around $ 250 per treatment course of five injections 1. The latest project planning shows that the clinical trial with palivizumab biosimilar will start in 2018.
UCAB – Utrecht palivizumab biosimilar network
In order to succeed in the palivizumab project, UCAB has several collaborating partners in Utrecht. Among them are the University Medical Center Utrecht, the Utrecht RSV Research Group, Julius Clinical (an Academic Clinical Research Organization in Utrecht), Bioceros and the department of Pharmaceutical Sciences of the Utrecht University.
Other projects with biotherapeutics on the WHO essential medicine list are under discussion. Depending on the nature of the product, UCAB has access to other scientific and business partners in the Utrecht area.