First biosimilar anti-cancer drug “quto-bead mono-resistance” passes WHO prequalification

A biosimilar to the breast cancer treatment drug Trastuzumab, which passed the World Health Organization’s prequalification today, is expected to significantly reduce drug costs, expand coverage and give women around the world access to the life-saving drug at a more affordable price. It is also the world’s first biosimilar drug to be prequalified by WHO medicines.

Breast cancer is the most common malignant tumor in women, with 2.1 million women worldwide in 2018, 630,000 of whom died, many of them due to late diagnosis or difficulty in accessing affordable drugs, the WHO said.

Quto-bee monobolite is an antibody that can attach to the lesions, block the growth of cancer cells, and stimulate the body’s immune system to destroy cancer cells, currently clinically mainly used to treat metastatic breast cancer, known as breast cancer “life-saving medicine.” It was included in the WHO Standard List of Essential Medicines as early as 2015 and is listed as a recommended drug in 20% of breast cancers, which is very effective in treating early-stage and some advanced breast cancers.

The name of the product, Herceptin, was produced by Swiss pharmaceutical giant Roche and approved for listing in the United States in 1988. In the U.S., the cost of a course of treatment for “Hercetin” is about $70,000, while in China, the price of each course has fallen from 330,000 yuan to about 35,000 yuan after it was covered in 2017.

The WHO says the average price of “Hercetine” in the global market is about $20,000, making it unaffordable for many patients and most of the country’s health systems, and that the prequalified biosimilar drug is about 65 per cent cheaper than “Hercetine”.

Biosimilars, also known as biosimilars, refer to biotherapeutic products similar to licensed market reference drugs, usually developed after the patent expires on the original product. Bringing biosimilardrugs to the market can help significantly reduce the price of drugs, making treatment available to more patients.

THE WHO SAYS SEVERAL HERCETINE BIOSIMILARS HAVE ENTERED THE MARKET IN THE PAST FIVE YEARS, BUT NONE OF THEM HAVE BEEN PRE-QUALIFIED BY THE ORGANIZATION. The pre-trial drug was provided by Samsung Biologics Netherlands, who assessed its efficacy, safety and quality to be comparable to Herceptin.

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