Improving access to medicines in middle- and low-income countries is dependent on effective regulatory oversight but, in many cases, medicines regulatory authorities (MRAs) in the developing world are unable to adequately carry out all functions (1). In the past, this approach lead to reliance on stringent regulators in developed countries, which is problematic because it puts the decisions in the hands of regulators who aren’t accountable for the needs and safety of the target patients. The World Health Organization (WHO) championed an alternative approach with their prequalification program; a team of assessors, which includes WHO staff and experts from national regulatory authorities, evaluates data presented by medicine makers. And a team of inspectors verifies that the manufacturing sites for the finished pharmaceutical product and its active pharmaceutical ingredient(s) comply with WHO good manufacturing practices. Once a decision is made, the medicine appears on the WHO’s list of prequalified medicines and can be purchased by international procurement agencies – such as UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNITAID – for distribution in resource-limited countries.
Traditionally, WHO prequalification focused on only a few diseases (in particular, HIV, malaria, and TB), with the majority of approved products being generic HIV drugs. However, the WHO has now launched a new pilot project for prequalifying biosimilar medicines (2). In September, drug manufacturers will be able to submit applications for prequalification of biosimilar versions of two products in the WHO Essential Medicines List: rituximab and trastuzumab. The WHO is also reportedly planning to explore options for prequalifying insulin (3). “Biosimilars could be game-changers for access to medicines for certain complex conditions,” said Dr Suzanne Hill, WHO’s Director of Essential Medicines and Health Products, in a press release. “But they need to be regulated appropriately to ensure therapeutic value and patient safety.” The WHO says it will also review the 2009 Guidelines on the evaluation of similar biotherapeutic products to “ensure that WHO’s guidance to national regulatory authorities reflects recent evidence and experience.”
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References
- M Moran et al., “Registering new drugs for low-income countries: the African challenge”, 8, e1000411 (2011). WHO, “WHO to begin pilot prequalification of biosimilars for cancer treatment”, (2017). Available at: http://bit.ly/2q1WOtp. Last accessed May 12, 2017. UN Daily News, “UN health agency to examine lower-cost ‘biosimilar’ drugs to expand access to cancer treatment”, (2017). Available at: http://bit.ly/2pEEfGP. Last accessed May 12, 2017.
