Is Herzuma (trastuzumab-pkrb) on the market?

Herzuma (trastuzumab-pkrb) is a biosimilar that was approved by the U.S. Food and Drug Administration (FDA) in December 2018 for the treatment of HER2-overexpressing breast cancer, based on clinical data. The marketed trastuzumab (trastuzumab) has similar biological properties. It is also used to treat adult patients with metastatic gastric cancer (gastric or gastroesophageal junction adenocarcinoma). It was developed by Celltrion Company and Teva Pharmaceutical Industries Co., Ltd. under the trade name Herzuma.

According to the European Medicines Agency's requirements for biosimilars, Herzuma has been proven to be of comparable quality, safety and efficacy to Herceptin, and therefore its benefits outweigh the identified risks. In 2018, the European Union granted Herzuma approval for marketing. Herzuma is currently available by prescription only, and treatment should be done under the supervision of a doctor experienced in the use of cancer drugs. It is available in powder form for use in preparing solutions to add to intravenous infusions (drips). Breast cancer patients should be infused over 90 minutes every week or every three weeks, and gastric cancer patients should be infused once every three weeks. For early-stage breast cancer, treatment is given for one year or until the disease returns, and for metastatic breast or stomach cancer, treatment is continued until it remains effective. Recommended dosage depends on the patient's weight, the condition being treated, and whether dosing is weekly or every three weeks.

Herzuma is not yet available in the domestic market, so it is not included in medical insurance. There is little information on its price and other related information. Patients in need should consult a medical consultant.