WHO announces biosimilars prequalification pilot

The World Health Organization (WHO) is to invite biosimilar manufacturers to participate in a pilot programme to prequalify biosimilars of two top selling biologic cancer treatments – Rituxan (rituximab) and Herceptin (trastuzumab).

The programme is the start of 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.

As well as launching its biosimilars prequalification pilot, the WHO is set to review its 2009 guidelines for evaluating biosimilars to ensure its advice is up-to-date.

The Organisation says it will work to encourage fairer prices for biological products and provide help countries develop price-setting strategies that foster sustainable markets to deliver treatments to patients.

Innovator biotherapeutic products are often too costly for many low- and middle-income countries, so biosimilars offer a way to expand access these medicines.

The programme will commence in September 2017.

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