WHO Prequalifies its First Biosimilar

Regulatory NewsRegulatory News
| 19 December 2019 | By Michael Mezher 

The World Health Organization (WHO) on Wednesday announced it has prequalified its first biosimilar, a year and a half after it invited manufacturers to submit applications for prequalifying biosimilars to two biologics on its Essential Medicines List, Roche’s Rituxan (rituximab) and Herceptin (trastuzumab).
The newly prequalified medicine is Samsung Bioepis’ Ontruzant, a biosimilar version of trastuzumab. WHO says it assessed the medicine and found it “comparable to the originator product in terms of efficacy, safety and quality,” making it eligible for procurement by many national health systems and by other United Nations agencies. Samsung Bioepis, which said Ontruzant received prequalification status after 13 months of WHO review, also said it's eligible to apply for accelerated registration in 41 countries.
“WHO prequalification of biosimilar trastuzumab is good news for women everywhere,” said WHO Director-General Tedros Adhanom Ghebreyesus, adding that “women in many cultures suffer from gender disparity when it comes to accessing health services. In poor countries, there is the added burden of a lack of access to treatment for many, and the high cost of medicines. Effective, affordable breast cancer treatment should be a right for all women, not the privilege of a few.”
According to WHO, the average cost of Rituxan is around $20,000, making it too costly for many healthcare systems in developing countries. WHO says it expects the biosimilar version to cost 65% less than Rituxan.
WHO also said it expects biosimilar prices to come down as more products are prequalified.


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