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由于生物制剂单克隆抗体的专利已经或即将到期,因此,生物类似药即将广泛地进入市场。此类药品的费用将逐渐降低,广大患者将更易应用到此类药物。由于在成人风湿类疾病患者以及儿童炎症性肠病患者仍缺乏足够的临床试验数据,因此,应用生物类似药仍需谨慎对待,并加以认真考量。与所有生物制剂一样,针对生物类似药在治疗儿童炎症性肠病方面的有效性、安全性及免疫原性,均需强制进行上市后监管。
Biosimilars are about to enter the market on a broad scale as patents for monoclonal antibodies to biological agents have been or are about to expire. The cost of such drugs will be gradually reduced, the majority of patients will be more easily applied to such drugs. Due to the lack of adequate clinical trial data in adults with rheumatic diseases and children with inflammatory bowel disease, the use of biosimilars remains cautious and carefully considered. Like all biological agents, post-marketing surveillance is mandatory for the effectiveness, safety and immunogenicity of biosimilars in the treatment of childhood inflammatory bowel disease.