【摘要】 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。更多还原

【Abstract】 Because the patents for biopharmaceutical monoclonal antibodies have or soon will expire,biosimilars are coming to the market widely. It will most likely lead to decreased drug costs and easier access to the expensive agents. Because of the limited available clinical data from adults with rheumatologic diseases and children with inflammatory bowel disease(IBD),use of biosimilars should be done with caution and needs some considerations.Postmarketing surveillance programs for efficacy,safety and immunogenicity should become mandatory in children with IBD using biosimilars,as with all biological drugs.更多还原