Analytical and Functional Similarity of the Biosimilar Candidate ABP 654 to Ustekinumab Reference Product.

ABSTRACT:

Background and objective

ABP 654 is a proposed biosimilar to ustekinumab reference product (RP), a human immunoglobulin isotype class G subclass 1 kappa monoclonal antibody that acts as an antagonist of interleukin (IL)-23 and IL-12. Ustekinumab RP is indicated for the treatment of some forms of plaque psoriasis, active psoriatic arthritis, Crohn's disease, and ulcerative colitis. ABP 654 and ustekinumab RP utilize different expression systems, and the purpose of this study was to assess analytical similarity between ABP 654 and ustekinumab RP sourced from the United States (US) and the European Union (EU).

Methods

The analytical testing plan included general properties, primary structure, higher-order structure, product-related substances and impurities, particles and aggre

SUBMITTER: Cantin G 

PROVIDER: S-EPMC10676326 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature