WHO to Launch Pilot to Prequalify Biosimilars

The World Health Organization (WHO) announced Tuesday that in October it will launch a pilot project for prequalifying biosimilars as part of its work to make some of the most expensive treatments for cancer more widely available in low- and middle-income countries.

The first "Expression of Interest," according to WHO, will cover both rituximab (Roche’s Rituxan) and trastuzumab (Roche’s Herceptin), and will be published in October 2017.

In Europe, there are five centrally authorized rituximab biosimilars but no authorized trastuzumab biosimilars yet. In the US, an FDA panel recommended the approval of a Herceptin biosimilar in July (a final decision is expected 3 December), while Celltrion and Teva recently said FDA has accepted for review their biosimilar to rituximab.

"To provide clear guidance to manufacturers wishing to apply for the pilot project, WHO will be using two assessment pathways, for applicants with products approved by a stringent regulatory authority and for applications with products that were approved by other NRAs [national regulatory authorities]," WHO said.

The agency is also currently finalizing three guidance documents that will be used to assess biosimilars, including:

• WHO pilot procedure for prequalification of similar biotherapeutic products
• WHO guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products approved by stringent regulatory authorities
• WHO guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products. Preparation of product dossiers in common technical document format

Questions can be submitted to: prequalbiosimilar@who.int.