The World Health Organization has prequalified a biosimilar of Roche Holding AG's breast cancer treatment Herceptin, or trastuzumab, in an effort to make the treatment with a global average cost of $20,000 more affordable and available to women globally.
The United Nations specialized agency for international public health prequalifies medicines to facilitate access with the goal of addressing widespread diseases in places with limited access to quality medicine.
Trastuzumab is the first biosimilar medicine that has been prequalified by the agency. The WHO added that the medicine, which was supplied by Samsung Bioepis NL BV, was similar in efficacy, safety and quality to original products and will be eligible for procurement by UN agencies and for national tenders.
In 2015, the WHO included trastuzumab in its essential medicines list for the treatment of about 20% of breast cancers due to the drug's high efficacy in curing early-stage breast cancer and in some instances more advanced form of the disease.
According to the WHO's estimates, 2.1 million women developed breast cancer in 2018, and 630,000 of those women died because of late diagnosis and lack of access to affordable treatment. Estimates by the WHO's International Agency for Research on Cancer put the number of diagnosed breast cancers to 3.1 million by 2040.
The U.S. Food and Drug Administration approved Samsungbioepis Co. Ltd.'s breast cancer drug Ontruzant, which is marketed by Merck & Co. Inc. in the U.S., in January. Pfizer Inc. has also developed a biosimilar of Herceptin that is branded as Trazimera and is approved to treat breast cancer in the U.S. and the EU.