[Ip-health] WHO launches pilot to prequalify biotherapeutics and biosimilars

BAGOZZI, Daniela bagozzid at who.int
Thu Jul 5 07:21:40 PDT 2018

Dear all,

WHO today launched a pilot project for prequalifying biotherapeutic medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries.
To that end, WHO is inviting manufacturers to submit applications for prequalification of two biotherapeutic 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) and their corresponding similar biotherapeutic products.

"Biosimilars represent effective cancer treatment options at a more affordable price," says Mariângela Simão, WHO Assistant Director General, Access to Medicines, Vaccines, Pharmaceuticals. "But we need to make sure that they are of good quality and safe, which is why prequalification will be a key step to expanding access to these medicines."
For more information: http://www.who.int/medicines/regulation/biotherapeutic_products/en/

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