The World Health Organization announced today that it will launch a pilot project in 2017 for prequalifying cancer biosimilar medicines, with the intent of lowering prices on some of the most expensive cancer treatments.
Biosimilars are medicines very similar to the original biotherapeutics, which are pharmaceutical products derived from biological and living sources. They are often “speciality drugs,” highly effective in treating medical conditions for which no other treatments are available, in particular cancer, and chronic diseases such as diabetes. However those medicines are also highly priced, according to the WHO.
The WHO press release states that the pilot project will be a “step towards making some of the most expensive treatments for cancer more widely available in low-and middle-income countries.”
According to the release, the WHO will invite manufacturers to submit applications for prequalification of biosimilar versions of two products in 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).
Biotherapeutics cannot be copied in the same way traditional medicines can, and no generic version of a biotherapeutic can be produced. Biosimilar products have to be comparable to the originator products in terms of quality, safety and efficacy, according to the WHO. If biosimilars submitted for prequalification meet those requirements, the medicines will be listed by WHO and become eligible for procurement by United Nations agencies, the release said.
As generic versions of branded medicines, biosimilars are expected to be cheaper than the original biotherapeutic. WHO “will advocate for fairer prices for all biotherapeutics to ensure that these treatments can truly benefit public health,” according to the release.
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, says the release.
[…] The WHO is considering whether to extend the prequalification process to manufacturers creating me-too versions of insulins, more commonly known as biosimilars. If a manufacturer of biosimilar insulin could, in theory, get its products prequalified, this stamp of approval could enable international agencies to buy it for patients in low and middle-income countries at lower prices than originator products. The agency has already given the go-ahead for pilots of some biosimilar cancer products (IPW, Public Health, 4 May 2017). […]