Biosimilars in crohn's disease

摘要

The patent for some biological medicines used in the treatment of Crohn's disease are close to expire. Biosimilars are biologicals sufficiently similar to a biopharmaceutical already approved by a regulatory agency.1 Several companies are developing biosimilars to tumor necrosis factor and the first biosimilar submitted to the European agency for the treatment of rheumatoid arthritis was developed in Korea by Celltrion and was approved by regulators. The review concluded that the biosimilar named Infectra has demonstrated similar quality efficacy and safety to Remicade. Their commendation was not only for its use in rheumatoid arthritis but also for the extrapolation for indication in other forms of inflammatory arthritis.2 Surprise as it may be extrapolation was also extended to Crohn's disease (CD).