Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI‐751): Results From a Randomized Phase 1 Trial

Abstract

BioFactura has developed a proposed biosimilar candidate (BFI‐751) to ustekinumab reference product. Results are reported for the first‐in‐human trial designed to compare the pharmacokinetic profiles, safety, and immunogenicity of BFI‐751 and ustekinumab reference products from the European Union and United States as well as similarity of the EU and US reference products. This was a multicenter, randomized, double blind, 3‐parallel‐group study (trial ID: NCT04843631). Healthy subjects were randomized to receive a single subcutaneous dose of 45 mg of BFI‐751, EU ustekinumab, or US ustekinumab. The pharmacokinetic parameters were area under the concentration–time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum concentration. Safety, tolerability, and immunogenicity data were also reported. Pairwise comparisons among the 3 treatments all met the standard bioequivalence criteria that the 90% confidence interval of the geometric mean ratios of AUC from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum concentration are completely within the acceptance interval of 80.00%–125.00%. There were no marked differences in the safety and tolerability profiles for subjects receiving BFI‐751 as compared to EU or US ustekinumab. Treatment‐emergent adverse events were mild to moderate for all treatment groups.

Biosimilars in Dermatology Review

“…Further, there has been progress made on several ustekinumab biosimilars. [47][48][49] The patents for ustekinumab will be expiring in 2023 in the USA, and 2024 in Europe, allowing for another class of biosimilars to enter the market. 50 While there are currently no FDA approved biosimilars of ustekinumab, both Alvotech and Amgen have biosimilar products under review by the FDA, along with another 6 biosimilars in development.…”