WHO initiative to widen availability of anti-cancer drugs

The World Health Organization will initiate a project this year to grant its stamp of approval to expensive anti-cancer medicines so that these are made widely available in India and other low- and middle-income countries.
The WHO has announced a pilot project to "prequalify" biosimilar versions of two drugs -- rituximab to treat chronic leukemia and traztuzumab used to treat breast cancer.
Prequalifitying these drugs will make them eligible for distribution in emerging markets.
The global health body said that it also plans to explore options for "prequalifying insulin".
A biosimilar is a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company.

"This year WHO will launch a pilot project for prequalifying biosimilar medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries," the global body said.

It said that in September, it 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).
The decision comes after a two-day meeting in Geneva between the WHO, national regulators, pharmaceutical industry groups, patient and civil society groups among others to discuss ways to increase access to biotherapeutic medicines.

Biotherapeutic medicines, which are produced from biological sources such as cells rather than synthesised chemicals, are important treatments for some cancers and other non-communicable diseases.
Like generic medicines, biosimilars can be much less expensive versions of innovator biotherapeutics and are usually manufactured by other companies once the patent on the original product has expired.
"As the patents of some biotherapeutics have expired, more biosimilars are being produced. Like generic medicines, biosimilars could help to increase access to treatment in lower-resourced countries and provide a solution to escalating health costs in high-income countries," the WHO said.
If the WHO finds that biosimilars submitted for prequalification are comparable to originator products in terms of quality, safety and efficacy, these medicines will be listed by the WHO and become eligible for procurement by United Nations agencies, it said.

Many low- and middle-income countries also rely on the WHO prequalification before buying medicines and an additional benefit of the WHO prequalification could be to increase competition and further reduce the price 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 Marie-Paule Kieny, WHO Assistant Director General for Health Systems and Innovation.
The WHO has also decided to review its 2009 guidelines on the evaluation of similar biotherapeutic products to ensure that the global body's guidance to national regulatory authorities reflects recent evidence and experience.

"Biosimilars could be game-changers for access to medicines for certain complex conditions. But they need to be regulated appropriately to ensure therapeutic value and patient safety," said Suzanne Hill, the WHO's Director of Essential Medicines and Health Products.
In addition, the WHO will advocate for fairer prices for all biotherapeutics to ensure that these treatments can truly benefit public health.
"This will include support to countries to develop price-setting strategies that foster sustainable markets to deliver treatments to patients, savings to payers and incentives to producers to keep manufacturing the medicines needed," it said.
Biotherapeutics are pharmaceutical products derived from biological and living sources and they include therapeutic vaccines, blood, blood components, cells, gene therapies, tissues and other materials.

Several biologic medicines are "specialty drugs", highly priced and effective in treating medical conditions for which no other treatments are available, the global health body said.