The World Health Organization (WHO) is to launch a pilot project this year to evaluate inexpensive copies of costly drugs for biotechnology cancer to make these drugs more accessible in the poorest countries.
The U.N. agency said it would invite drug manufacturers to submit applications for prequalification of the so-called biosimilar versions of two of these drugs on the essential medicines list, Roche Rituxan and Herceptin. WHO is also considering exploring options for pre-qualification biosimilar insulin.
The program is also used by many governments to guide the bulk purchase of drugs. "Innovative 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 drugs," said Deputy Director General WHO, Marie-Paule Kieny.
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 drugs, which are manufactured inside living cells, means that copies can never be exactly the same as the original ones. But an increasing number of these drugs have been approved quite similar to do the work in several markets.
The movement is an impetus for biosimilars, which should represent an increasing proportion of treatments, particularly for cancer, as patents on brand-name products expire. WHO plays a key role in monitoring the quality of medicines in the poorest countries through its screening program, which ensures that treatments provided by UN agencies.
