Amgen Launches Phase III Clinical Trial for Nivolumab Biosimilar ABP206

On June 19, a Phase III clinical trial initiated by Amgen was registered on the ClinicalTrials.gov website. It aims to evaluate the pharmacokinetic (PK) similarity, efficacy, safety, and immunogenicity of ABP206 and nivolumab (Opdivo) in patients with melanoma.

This study is a randomized, double-blind clinical trial planning to enroll 249 patients with stage III or IV melanoma who have not received prior anticancer drug treatment. Patients will be randomly assigned in a 1:1:1 ratio to receive either ABP206, FDA-approved O药, or EU-approved O药. The primary endpoints of the study are the area under the serum concentration-time curve (AUC0-28d) within 28 days and the area under the serum concentration-time curve during the steady-state dosing interval in weeks 17-21 (AUCtau_SS). The study is expected to commence in July 2023 and conclude in July 2025.

Based on the previous biosimilar product numbering in Amgen's R&D pipeline, ABP206 is highly likely to be a biosimilar of Opdivo.

Currently, there are a total of 8 Opdivo biosimilars under development globally, with only 3 in clinical stages. Among them, Amgen's ABP206 is the most advanced. The other two products in clinical development come from Boan Biotech (LY01015) and Mabtech/Biommune (CMAB819). Opdivo’s competitor, Keytruda, is also facing potential threats from biosimilars, with 10 related products under development. The most advanced of these has reached Phase III (MB12, Laboratorio ELEA). Henlius has developed HLX17, a biosimilar of Keytruda, but the product has not yet entered clinical trials.

The U.S. sequence patents for O and K drugs will expire in 2027 and 2028, respectively, while the Chinese sequence patents will expire in 2026 and 2028, respectively.

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