Jongsma Maria Myrthe Elisabeth, Vulto Arnold, de Ridder Lissy
aDepartment of Pediatric Gastroenterology, Erasmus Medical Center/Sophia Children's Hospital bDepartment of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, The Netherlands.
Curr Opin Pediatr. 2017 Oct;29(5):560-565. doi: 10.1097/MOP.0000000000000529.
After expiry of the patent of originator anti-tumor necrosis factor drug infliximab (Remicade), CT-P13 was in 2013 the first infliximab biosimilar to be approved by the European Medicine Agency (EMA) for the same indications as the reference drug, including paediatric inflammatory bowel disease (IBD). The approval was based on extrapolation, after extensive in-vitro studies and clinical experience in patients with ankylosing spondylitis and rheumatoid arthritis. The extrapolation of CT-P13 to IBD and to paediatric patients raised concerns among paediatric IBD specialists.
Now, almost 4 years later, we can conclude that those concerns have been resolved. There are a growing number of postmarketing studies and real-life data, so far mostly in adults and some in children with IBD. These studies show reassuring comparable efficacy, safety and immunogenicity between CT-P13 and the reference Infliximab.
In Europe, biosimilars are increasingly regularly prescribed drugs in paediatric IBD. Due to their lower cost, treatment expenses have gone down considerably (up to 30% or more in some countries) and patient access has improved. However, additional well designed studies to investigate long term follow-up of biosimilars in children are still needed. In addition, clinical studies addressing pharmacokinetics, pharmacodynamics and optimal use of infliximab (originator as well as biosimilar) are still desirable.
原研抗肿瘤坏死因子药物英夫利昔单抗（类克）专利到期后，CT-P13于2013年成为首个获欧洲药品管理局（EMA）批准用于与参比药物相同适应症的英夫利昔单抗生物类似药，包括儿童炎症性肠病（IBD）。该批准基于在强直性脊柱炎和类风湿关节炎患者中进行的广泛体外研究及临床经验后进行的外推。将CT-P13外推至IBD及儿科患者引发了儿科IBD专家的担忧。
如今，近4年后，我们可以得出结论，这些担忧已得到解决。上市后研究及真实世界数据越来越多，目前大多针对成人，也有一些针对IBD儿童。这些研究表明，CT-P13与参比英夫利昔单抗在疗效、安全性和免疫原性方面具有令人安心的可比性。
在欧洲，生物类似药在儿科IBD中越来越常被处方。由于其成本较低，治疗费用大幅下降（在一些国家高达30%或更多），患者可及性得到改善。然而，仍需要更多设计良好的研究来调查生物类似药在儿童中的长期随访情况。此外，仍需要开展针对英夫利昔单抗（原研药及生物类似药）药代动力学、药效学及最佳使用方法的临床研究。
