WHO Consults On Kick-Starting Pilot On Prequalification Of Biosimilars
The World Health Organization is making inroads into its plan to prequalify biosimilars, starting with a pilot project involving two anti-cancer medicines. It has developed two assessment pathways to prequalify biosimilars, depending on whether not these products are already approved by a stringent regulatory authority. During the pilot phase, the fees associated with prequalification will be waived.
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European research-based pharmaceutical industry association, EFPIA, says it "makes sense" for the World Health Organization to review the concept of "stringent regulatory authorities," which is linked to a country's membership of the International Council for Harmonisation.
The World Health Organization is to pilot the prequalification of biosimilars in a bid to make expensive cancer treatments more widely available to patients. Ritixumab and trastuzumab will be first in line. The EU generics and biosimilars industry has welcomed the initiative, saying the introduction of biosimilars in the field of oncology could lead to significant changes to standards of care for patients.
The UK’s deployment of COVID-19 vaccines has left vaccine manufacturers worried about emerging discussions on dosing strategies that may not be supported by authorized labeling or published clinical data.