The WHO is expected to move forward with the pilot prequalitication project of biosimilar versions of two drugs on the WHO Essential Medicines List: rituximab (used principally to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukemia), and trastuzumab (used to treat breast cancer). The WHO will issue its first invitation for manufacturers to submit an expression of interest (EOI) concerning these oncological products in the upcoming weeks. The EOI for oncological biosimilars will be the first such call issued for drugs aiming to treat noncommunicable diseases (NCDs).

The EOI for cancer biosimilars extends the scope of medicines’ prequalification into a new and important therapeutic area. Numerous patents for biotherapeutic products (equivalent to innovator products) have expired while the production of biosimilar (equivalent to generic) products is increasing, meaning the time is ripe for targeting oncological biosimilars’ prequalification.

Similarly to generic medicines, biosimilars could increase treatment accessibility in low- and middle-income countries (LMICs), while also reducing the price escalation in health costs for high-income countries.

Funds are now being sought to expand prequalification to a wide variety of products. For instance, though cancers account for 8.8 million deaths, cardiovascular diseases (CVD) account for a vastly higher 17.7 million victims, presenting an incentive to cover not only antihypertensive medicines but also blood pressure monitors. WHO also plans to explore options for insulin prequalification, for treating diabetes, an increasingly common ailment: its incidence rose from 108 million in 1980 to 422 million in 2014.