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 The U.N. agency said on Thursday it would invite drugmakers in
September to submit applications for prequalification of so-called
biosimilar versions of two such drugs on its essential medicines
list, Roche's Rituxan and Herceptin.
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 U.N. 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-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.
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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.
(Reporting by Ben Hirschler; editing by David Clarke)
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