World Health Organization (“WHO”) Prequalifies Biosimilar Trastuzumab – WHO’s First Biosimilar

Today, the World Health Organization (“WHO”) prequalified Samsung Bioepis’s breast cancer biosimilar trastuzumab – WHO’s first biosimilar prequalification.  Prequalification is “a service provided by WHO to assess the quality, safety and efficacy of those products that address global public health priorities.”  The WHO noted that the global average price of originator trastuzumab is $20,000 and that the biosimilar will be generally 65% cheaper than the originator.  WHO assessed the trastuzumab biosimilar from Samsung Bioepis NL B.V. (Netherlands) in terms of efficacy, safety and quality, and prequalified it for procurement by United Nations agencies and for national tenders.  WHO adds that their prequalification “gives countries the assurance that they are purchasing quality health products” and “could make this expensive, life-saving treatment more affordable and available to women globally.”

Download PDF