WHO Prequalifies Second Celltrion Healthcare Biosimilar

Herzuma, a biosimilar form of trastuzumab that was launched in the United States in March, has received World Health Organization (WHO) prequalification status, a Celltrion Healthcare spokesman confirmed.

Trastuzumab is used for the treatment of breast cancer, and the drug has been on WHO’s list of essential medicines since 2015. About 2.1 million women contracted breast cancer in 2018 and 630,000 died from the disease, often because of late diagnosis and poor access to affordable treatment, according to WHO.

Trastuzumab is used in breast cancers that express HER2, a gene that is associated with a faster rate of cancer growth and is present in 15% to 20% of breast cancers and in some gastric cancers.

WHO Prequalification Status

WHO prequalification status is based on an assessment of the quality, safety, and efficacy of medicines and is intended to give providers the confidence to use medicines that are needed for high priority health concerns.

WHO has prequalified both the 150 mg and 420 mg versions of Herzuma. This is the second WHO prequalification for the Republic of Korea-based company. In May, Celltrion’s rituximab biosimilar (Truxima), used for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia, received WHO prequalification status, becoming the first rituximab product to gain that distinction.

Biosimilars offer a lower-cost alternative and are especially useful in lower income countries. The average global cost of trastuzumab from sources that provide the originator product, Herceptin, is $20,000, which “puts it out of reach for many women and health care systems in most countries,” WHO stated in December 2019.

This makes the second trastuzumab biosimilar to make WHO’s list of prequalified medicines. The first was a Samsung Bioepis medicine, Ontruzant, in December 2019, which WHO noted was 65% cheaper than the originator product. Ontruzant was launched in the United States in April 2020.

Herzuma was launched in the United States in March 2020 via Teva, a Celltrion partner. It received European Medicines Agency authorization in 2018.

According to a recent study, delays for treatment of breast cancer in sub-Saharan Africa (Uganda, Nigeria and Namibia) are often lengthy. Of 1325 women, cancer treatment was not initiated for at least a year for 17% of women and 14% of women with stage I-III disease. The untreated percentages were significantly higher in 2 regional Nigerian hospitals (38%).