Samsung Bioepis biosimilar wins WHO’s prequalification

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Samsung Bioepis biosimilar wins WHO’s prequalification

Ontruzant, a cancer treatment from Samsung Bioepis, has received a prequalification from the World Health Organization (WHO), the first biosimilar medicine ever to win that designation.

Prequalified medicines are those that have been deemed acceptable for procurement by United Nations agencies. They also tend to be fast-tracked for domestic approval in developing countries.

Ontruzant is a biosimilar of Roche’s Herceptin breast cancer treatment, which is a trastuzumab therapy.

Biosimilars are biological products approved based on evidence that they are highly similar to approved products. They have no meaningful clinical differences in terms of safety or effectiveness from the reference product.

While the WHO has reviewed a few other trastuzumab biosimilars over the past five years, none of them have been prequalified by the organization, as they did not meet its quality and safety standards.

The organization used to provide the prequalification only for vaccines but later in 2018 extended the program to trastuzumab and rituximab.

“Women in many cultures suffer from gender disparity when it comes to accessing health services,” WHO Director-General Tedros Adhanom Ghebreyesus said in a statement Thursday. “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.”

Trastuzumab has been included in the WHO’s essential medicines list since 2015 as a viable treatment for about 20 percent of breast cancers, as the substance has shown high efficacy in curing early-stage breast cancer and even curing more advanced cases.

By some the biosimilar version, the WHO expects that it can help women in many countries benefit from the product being more affordable. The WHO said the global average cost of trastuzumab is $20,000, but by getting the biosimilar version from Samsung Bioepis, the cost can be around 65 percent cheaper.

The global health authority said the prequalification can ensure that price drops even further.

According to the WHO’s International Agency for Research on Cancer, the greatest number of breast cancer diagnoses will be in low- and middle-income countries.

Samsung Bioepis said that the prequalification provides a great opportunity for the company and its Ontruzant to gain stronger foothold in the global market.

“Our first anti-cancer treatment Ontruzant has gained a great opportunity to be supplied worldwide through an international entity,” a spokesperson for Samsung Bioepis said.

“We will continue working to provide treatment opportunities for a greater number of patients with high-quality bio medicines in reasonable prices.”

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