WHO Launches Biosimilar Pilot Program

Print 12 May 2017
BioPharm International

The World Health Organization (WHO) is launching a pilot project to make biosimilars for the treatment of cancer more widely available in low- and middle-income countries. In a May 4, 2017 press release, WHO said that in September 2017 it will be inviting manufactures to submit applications for prequalification of biosimilar versions of rituximab and trastuzumab, both of which are on the WHO Essential Medicines List.

The decision comes after a two-day meeting in Geneva between WHO, national regulators, pharmaceutical industry groups, patient and civil society groups, payers, and policymakers to discuss ways to increase access to biotherapeutic medicines, WHO said. WHO also plans to explore options for prequalifying insulin.

“Innovator biotherapeutic products are often too expensive for many countries, so biosimilars are a good opportunity to expand access and support countries to regulate and use these medicines,” said Marie-Paule Kieny, PhD, WHO assistant director general for Health Systems and Innovation, in a statement.

According to WHO, if the organization finds the biosimilars submitted comparable to innovator products in safety, quality, and efficacy, the medicines will be listed by WHO and become eligible for procurement by United Nations agencies. Low- and middle-income countries often rely on WHO prequalification before buying medicines, the organization noted. WHO said it will also review its 2009 Guidelines on the Evaluation of Similar Biotherapeutic Products to ensure that its guidance to national regulatory authorities reflects recent evidence and experience.

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