WHO to bring cheaper biosimilar versions of cancer drugs to poorer countries

May 5, 2017

The World Health Organization (WHO) is moving to bring cheaper biosimilar versions of expensive biotech cancer drugs to poorer countries in order to make such medicines more widely accessible to patients.

WHO is launching a pilot project this year to assess cheap copies of two such drugs on its essential medicines list, Roche’s Rituxan and Herceptin. The UN agency will invite drugmakers in September to submit applications for prequalification of so-called biosimilar versions of the two drugs.

WHO also plans to explore options for prequalifying biosimilar insulin.

The move is a boost for biosimilars which are expected to account for a growing proportion of treatments, particularly for cancer, as patents on the original branded products expire.

The WHO plays a critical role in monitoring drug quality in poorer countries through its prequalification program, which ensures that treatments supplied by UN agencies such as UNICEF are of acceptable quality.

The program is also used by many governments to guide the bulk purchase of medicines.

“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 WHO Assistant Director General Marie-PauleKieny.

Roche’s Rituxan, known generically as rituximab, is used principally to treat blood cancers, while Herceptin, or trastuzumab, is a treatment for breast cancer.

The complex nature of biological medicines, which are made inside living cells, means copies can never be exactly the same as the original. But a growing number of such drugs have been approved as similar enough to do the job in several markets.


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