WHO to Begin Cancer Biosimilar Prequalification Pilot This Fall

Regulatory NewsRegulatory News
| 04 May 2017 | By Michael Mezher 

The World Health Organization (WHO) on Thursday announced it will invite biosimilar makers to participate in a pilot program to prequalify biosimilars of two top selling biologics this September in an effort bring lower cost versions of the products to low- and middle-income countries.

The two cancer treatments—Roche's Rituxan (rituximab) and Herceptin (trastuzumab)—make the top ten list for highest grossing drugs worldwide and cost in the tens of thousands of dollars per year in the US. The European Medicines Agency in late April recommended two rituximab biosimilars from Sandoz and others are in development for US Food and Drug Administration approval. A handful of companies, including Mylan, Amgen and Samsung Bioepis and Pfizer are also developing trastuzumab biosimilars.

"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," said Marie-Paule Kieny, WHO assistant director general for health systems and innovation.

The announcement is the first step towards incorporating biosimilars into WHO's prequalification scheme, which currently works to review drugs, active pharmaceutical ingredients (API), vaccines and in vitro diagnostics for procurement by UN agencies and developing countries, many of which rely on WHO's assessments.

Down the road, WHO says it will also look at its options for prequalifying copies of insulin products.

In addition to launching its biosimilars prequalification program, WHO says it will review its 2009 guidelines for evaluating biosimilars to ensure its advice "reflects recent evidence and experience."

WHO also says it will work to promote "fairer prices" for biological products and provide "support to countries to develop price-setting strategies that foster sustainable markets to deliver treatments to patients."



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