WHO pre-qualifies first biosimilar medicine


  • Dawn O'Shea
  • Univadis Medical News
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The World Health Organization (WHO) has announced that it has pre-qualified its first biosimilar medicine - trastuzumab - in a move that it hopes will make the treatment more affordable and accessible globally.

Trastuzumab was included in the WHO Essential Medicines List in 2015. However, the yearly cost of trastuzumab from originator companies can be approximately €17,900, a price that puts it out of reach for many women and healthcare systems. The biosimilar version is generally 65 per cent cheaper and the WHO expects the pre-qualification of this biosimilar, with more products in the pre-qualification pipeline, to reduce prices.

The pre-qualification process assesses the quality, safety and efficacy of products that address global public health priorities. If the product meets international standards, it is listed as eligible for procurement by United Nations agencies and for national tenders.

In July 2018, WHO launched a pilot project expanding the scope of pre-qualification to two biotherapeutic medicines. Trastuzumab biosimilar was assessed by the WHO and found comparable to the originator product in terms of efficacy, safety and quality. It is the first biotherapeutic to be pre-qualified as part of the pilot.