Pharmacokinetics and safety of CT-P17 (40 mg/0.4 ml) versus reference adalimumab: randomized study in healthy Japanese adults.

CT-P17 is a biosimilar that has been determined by the EMA to be highly similar to adalimumab. CT-P17 is approved to treat the same inflammatory conditions as reference adalimumab. CT-P17 is formulated at a high concentration (40 mg/0.4 ml) and may be associated with less injection-site pain than the original lower-concentration formulation of the reference product. In this study, healthy Japanese adults were given a single dose of either CT-P17 or EU-approved reference adalimumab. Pharmacokinetics (drug absorption, distribution, metabolism and excretion), safety and immunogenicity (occurrence of immune response to the drug) were comparable between the two groups. Previous studies with CT-P17 did not take place in Japan. These results support applying the conclusions regarding CT-P17 biosimilarity from other studies to the Japanese population.