Comparison of two biosimilarity studies of FKB327 with the adalimumab reference product: randomized phase 1 studies of single-blind, single-dose subcutaneous injection in healthy Japanese male participants

• Main Authors: Takuma Yonemura (Author), Rie Yazawa (Author), Miwa Haranaka (Author), Kazuki Kawakami (Author), Masayuki Takanuma (Author), Takumi Kanzo (Author), Dimitris Stefanidis (Author), Yasumasa Arai (Author)
• Format: Book
• Published: BMC, 2022-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract Background FKB327 has been developed as a biosimilar of the adalimumab reference product (RP). We compared the pharmacokinetics (PK), safety, and immunogenicity of FKB327 with those of the adalimumab RP after a single dose by subcutaneous (SC) injection in Japanese male participants. Method...