WHO Begins Biosimilar Pilot Program For Low-Income Countries


The World Health Organization (WHO) has announced that it will be beginning a new pilot program for biosimilars in low to middle income countries. The program will begin by prequalifying biosimilars of two top selling biologics-Roche’s Rituxan (rituximab) and Herceptin (trastuzumab).

The WHO will likely be working with companies such as Sandoz, Mylan, Amgen, and Samsung Bioepis, companies which are developing rituximab and trastuzumab biosimilars. Currently, Rituxan and Herceptin are among the top ten highest grossing drugs in the world and cost tens of thousands of dollars in the United States, making them unaffordable biologics in many areas of the world. The WHO’s program will aim to remedy this problem in several countries.

Marie-Paule Kieny, the assistant director general for health systems and innovation, released a statement on the pilot program. “Innovator biotherapeutic products are often too expensive for many countries, so biosimilars are a good opportunity to expand access and support to countries to regulate and use these medicines,” she said.

The WHO ultimately wants to incorporate biosimilars into its prequalification scheme. Currently, the scheme reviews APIs, drugs, vaccines, and in vitro diagnostics to be procured by UN agencies for use in developing nations. The WHO also said that it is looking got prequalify copies of insulin products in the future.

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