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Manufacture Biosimilars

WHO Wants to Put Biosimilars to the Test

The newest cancer medicines are considered expensive for developed countries – and they are completely out of reach for most low- and middle-income countries. In 2017, the WHO announced a pilot project for prequalifying two biosimilar medicines for cancer (1) – with the hopes of increasing access to treatment.

The WHO’s prequalification programs ensure that medicines meet acceptable standards of quality, safety and efficacy – and their lists of prequalified medicines are frequently used by international procurement agencies and countries to guide their decisions around bulk purchases of medicines. WHO prequalification (launched in 2001) initially focused on treatments for HIV, tuberculosis and malaria, but the remit was extended in 2006 and 2008 to cover medicines for reproductive health, and zinc for managing acute diarrhea in children, respectively.

The decision to investigate prequalification of biosimilars was made following a two-day meeting in Geneva in 2017 between WHO, national regulators, pharma industry groups, patient and civil society groups, payers and policymakers. Discussions focused on how to increase access to biotherapeutic medicines. The first two biosimilar cancer drugs to be studied for prequalification are rituximab (non-Hodgkin’s lymphoma and chronic lymphocytic leukemia) and trastuzumab (breast cancer). The WHO is also exploring options for prequalifying insulin.

According to the WHO, draft guidelines have been prepared and shared with stakeholders for consultation. “After the consultation process is over, WHO will issue an expression of interest letter inviting interested manufacturers to submit the two cancer medicines for assessment by WHO. We’re expecting this to happen by the end of June, and then it will depend on the quality of the information submitted as to how fast WHO can assess the products, inspect the manufacturing sites and make a final decision on whether to prequalify or not,” explained the WHO in an emailed statement.

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  1. World Health Organization, “WHO to begin pilot prequalification of biosimilars for cancer treatment” (2017). Available at Accessed April 26, 2018.
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