허셉틴과 바이오시밀러 신약

초록

Currently, with the advent of protein and cell therapy, new drug drugs are largely divided into synthetic drugs and biopharmaceuticals, and biopharmaceuticals are composed of proteins, cells, or nucleic acids, and are sensitive to minute changes such as temperature, moisture, and vibration in the production and distribution process, so it is important to maintain safety and effectiveness. Biopharmaceuticals have a long period of preclinical, clinical, and approval from the patent application, so the period is short. When the patent expires, a 'biosimilar' manufactured with similar ingredients is released in the market with high competitiveness. This review examines new drugs with trastuzumab (Herceptin) IgG1 antibodies and their biosimilars that have been approved by the FDA, and reports a comparative analysis of the efficacy and safety of these drugs. Herceptin targets the HER2 receptor, which is overexpressed in breast cancer, by Genetech Pharmaceutical Company in the United States, and is an antibody drug used to treat breast and stomach cancer, and it was first approved by the FDA as an original product. Herceptin's five biosimilars are Kanjinti, Ogivri, Herzuma, Ontruzant, and Trazima, and each other pharmaceutical company has been recognized for having similar efficacy and safety to the existing Herceptin. Herceptin and biosimilars can differ in price, manufacturing process, development and approval process. Herceptin and its biosimilars show similar therapeutic effects and safety, which contributes to the commercialization and increased accessibility of biopharmaceuticals. It also increases accessibility at low prices, similar efficacy and safety, and in areas with low supply. For these reasons, it is widely sold worldwide. Although a separate immunoassay is not required in general, it may be necessary to evaluate the immune status according to the underlying disease, immunosuppression status, and previous drug use history of a particular patient. It is important to consult a doctor according to the patient's individual situation to determine the necessary test. Future research on biosimilars needs to focus on evaluating the long-term safety and efficacy of these products.

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