Is Trastuzumab injection (subcutaneous injection) (Herceptin Hylecta) on the market?

Trastuzumab injection (subcutaneous injection) (Herceptin Hylecta) was approved for marketing by the U.S. Food and Drug Administration (FDA) in February 2019 in the United States, with the trade name Herceptin Hylecta, a monoclonal antibody that binds to the human epidermal growth factor receptor 2 (HER2) protein, binds to hyaluronidase and provides an alternative dosage form for patients with breast tumors that overexpress HER2. Trastuzumab injection (subcutaneous injection) was approved for medical use in the EU in August 2013.

Trastuzumab injection (subcutaneous ) contains a fixed dose of 600 mg of trastuzumab (5 mL solution) combined with recombinant human hyaluronidase PH20, an enzyme that temporarily degrades the extracellular matrix, allowing for the absorption of large volumes of solution. Degradation of the extracellular matrix is u200bu200btransient, favoring injectable solutions with minimal tissue deformation, edema, or tissue irritation. Subcutaneous injection of trastuzumab has been shown to have significant efficacy in the treatment of HER2-positive breast cancer. Compared with other dosage forms, subcutaneous injection dosage forms do not require loading doses and weight-adjusted doses, and there is no need to reformulate or calculate doses based on body weight, thus simplifying administration.

It is understood that the original drug of trastuzumab injection (subcutaneous injection) has been launched in China, but the specific price and other relevant information are not yet clear. Since the drug has been on the market for a short time, it has not been included in the scope of medical insurance. At present, there are no generic drugs of Trastuzumab injection (subcutaneous injection) produced and marketed. For more information and specific prices of Trastuzumab injection (subcutaneous injection), please consult a medical consultant.