Phase 1 Study of Proposed Infliximab Biosimilar Shows High PK Similarity to Remicade

Genor Biopharma, a China-based drug developer that is engaged in development of a number of biosimilars targeting oncology and inflammatory indications, has completed a phase 1 study of a proposed infliximab biosimilar, GB242, referencing Remicade. Results of the study were published in BioDrugs.

The investigators conducted the randomized, double-blind, parallel-controlled study in 48 healthy subjects in a single center. The volunteers were assigned to receive either the proposed biosimilar or the reference infliximab at a dose of 3 mg/kg. Blood samples were collected to assess pharmacokinetics (PK) and immunogenicity, and safety was assessed throughout the study.

PK similarity was concluded if the 90% CIs for the geometric mean ratios of the biosimilar and the reference for maximum concentration (C_max), area under the concentration—time curve (AUC) from time zero to the last quantifiable concentration (AUC_t), and AUC from time zero to infinity (AUC_∞) fell within the prespecified bioequivalence margin of 80% to 125%.

The authors report that the mean serum concentration—time curves were similar between the biosimilar and reference, and the 90% CIs for the geometric mean ratios of the 2 products for C_max, AUC_t, and AUC_∞ were contained within the 80% to 125% margin, and therefore the products demonstrated bioequivalence.

The proportion of volunteers who experienced treatment-emergent adverse events was similar between the groups, as were antidrug antibody profiles.

According to the authors, the study showed high PK similarity between the proposed biosimilar and its reference, and the drugs showed similar safety and immunogenicity.

According to Genor, the proposed biosimilar product has now moved to phase 3 development.

Among the other biosimilars being developed by the company are GB221, a proposed trastuzumab in phase 3 development; GB232, a proposed adalimumab in phase 1 development with partners; GB222, a proposed bevacizumab entering phase 3 development; and GB241, a proposed rituximab in phase 1 development with partners.

Reference

Zhang T, Chen G, Liu C, et al. A phase 1 study comparing the pharmacokinetics, safety, and immunogenicity of proposed biosimilar GB242 and reference infliximab in healthy subjects. BioDrugs. 2019;33(1):93-100. doi: 10.1007/s40259-018-0326-x.