BioDrugs (2017) 31:349–355 DOI 10.1007/s40259-017-0230-9 ORIGINAL RESEARCH ARTICLE LBEC0101, A Proposed Etanercept Biosimilar: Pharmacokinetics, Immunogenicity, and Tolerability Proﬁles Compared with a Reference Biologic Product in Healthy Male Subjects 1,2 2 2 1,2 • • • • Heechan Lee Hyewon Chung SeungHwan Lee Howard Lee 3 2 2 2 • • • • Sung Mo Yang Seo Hyun Yoon Joo-Youn Cho In-Jin Jang Kyung-Sang Yu Published online: 27 May 2017 Springer International Publishing Switzerland 2017 Abstract and AUC of LBEC0101 to Enbrel were 1.02 inf Objectives We performed this study to compare the phar- (0.92–1.13) and 0.96 (0.87–1.05), respectively, which were macokinetic (PK), immunogenicity, and tolerability pro- within a conventional bioequivalence criteria of 0.80–1.25. ﬁles of etanercept between LBEC0101, a proposed ADA development was also comparable. Both drugs were biosimilar, and Enbrel , the reference biological product. well tolerated. Methods A randomized, double-blind, single-dose, two- Conclusions LBEC0101 showed similar PK, immuno- treatment, two-period, two-sequence, crossover study was genicity, and tolerability proﬁles to Enbrel after a single conducted in 48 healthy males. In each period, a single subcutaneous injection in healthy males. LBEC0101 can be dose of LBEC0101 or Enbrel was subcutaneously injec- further developed as a potential etanercept biosimilar ted
BioDrugs – Springer Journals
Published: May 27, 2017
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