WHO Commits to Biosimilar Medicine Prequalification Program to Encourage Competition (and Lower Prices)

The World Health Organization (WHO) has plans to launch, later this year, a new pilot program to more accurately assess cheap copies of expensive biotech cancer drugs as a means to make these medicines more widely available to those who live in poorer countries.

The United Nations agency said, on Thursday, that it would be willing to invite drug makers to submit their applications, in September, in order to prequalify for a biosimilar versions of two such drugs on its essential medicines list: Rituxan and Herceptin, both from Roche Pharmaceuticals. These are also known as rituximab and trastuzumab, their genetic names.

“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,” comments Dr Marie-Paule Kieny, the WHO Assistant Director General for Health Systems and Innovation.

Biological medicines, of course, are very complex in nature. These drugs are made inside living cells and that means you can’t simply make a copy that is exactly the same as its original (and that no two copies are going to be the same). Still, an increasing number of these drugs have been approved as similar enough to accomplish their treatments in many markets.

If the WHO can find that the biosimilars submitted for prequalificaiton are, in fact, comparable to their originals in terms of safety, quality, and efficacy the agency could list the medicines for procurement by the agencies of the United Nations. This, the agency says, will impact many low- and middle-income countries which rely on WHO prequalification before buying any medicines. Another benefit to this, of course, would be increasing competition within the market to continue reducing the price of these very important medicines.

“Biosimilars could be game-changers for access to medicines for certain complex conditions,” explains WHO Director of Essential Medicines and Health Products, Dr Suzanne Hill. “But they need to be regulated appropriately to ensure therapeutic value and patient safety.”

In addition to launching this biosimilars prequalifications program, the WHO says it will review its previous guidelines, from 2009, which evaluated biosimilars to ensure the advice it can give “reflects recent evidence and experience.” Finally, the WHO says it will continue to work at promoting “fairer prices” in order to “support to countries to develop price-setting strategies that foster sustainable markets to deliver treatments to patients.”

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