Celltrion is a biopharmaceutical company headquartered in Incheon, South Korea. Celltrion Healthcare conducts worldwide marketing, sales, and distribution of biological medicines developed by Celltrion. Celltrion's founder, Jung Jin Seo, is the richest person in South Korea.
AimsTo demonstrate pharmacokinetic equivalence of CT-P39 administered via auto-injector (CT-P39 AI) and European Union-approved reference omalizumab via pre-filled syringe (EU-OMA PFS) in healthy Japanese adults.Participants & MethodsThis open-label, Phase 1 study randomized participants (1:1) to a single 150 mg/mL dose of CT-P39 AI or EU-OMA PFS. The primary endpoint was pharmacokinetic equivalence per area under the concentration-time curve from time zero to infinity (AUC0-inf) and maximum serum concentration (Cmax). Equivalence was concluded if the 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were contained within the predefined 80-125% equivalence margin. Secondary endpoints comprised additional pharmacokinetics, pharmacodynamics, safety, and immunogenicity.ResultsOverall, 65 and 64 individuals were randomized to CT-P39 AI and EU-OMA PFS, respectively. Pharmacokinetic equivalence between CT-P39 AI and EU-OMA PFS was demonstrated for both AUC0-inf (ratio of gLSMs [90% CI] 101.66 [95.31-108.45]) and Cmax (93.91 [87.20-101.14]). Thirty-nine (60.0%; CT-P39 AI) and 32 (50.8%; EU-OMA PFS) participants experienced treatment-emergent adverse events (TEAEs) with no serious TEAEs. Secondary endpoints were comparable between groups.ConclusionsCT-P39 AI was pharmacokinetically equivalent to EU-OMA PFS following a single dose in healthy Japanese individuals; pharmacodynamics, safety, and immunogenicity were comparable.
The primary objective of the MEGA-J study (UMIN-CTR number UMIN000057308) was to assess the safety of CT-P13, an infliximab biosimilar, in Japanese patients with Crohn's disease (CD), ulcerative colitis (UC), and/or rheumatoid arthritis (RA) after switching from reference infliximab. Data were collected over 5 years, following initiation of CT-P13 treatment within routine clinical practice. Interim findings are reported (cut-off: last patient's Year 2 visit). The primary endpoint was the incidence of uncommon adverse drug reactions (ADRs), including tuberculosis and serious infections. Overall, 220 patients were enrolled (123 CD; 74 UC; 23 RA). Forty-eight (39.0%), 37 (50.0%), and 3 (13.0%) patients reported ≥1 uncommon ADR in the CD, UC, and RA groups, respectively. The majority (94.3%) were unrelated to CT-P13. No cases of tuberculosis and one unrelated case of serious infection was reported. Nineteen (8.6%) patients discontinued treatment for reasons related to CT-P13. Overall, CT-P13 was well tolerated, demonstrating the safety of long-term treatment in real-world practice.
