ABP 206

ABP 206 is a nivolumab biosimilar developed by Amgen. It's currently being evaluated in clinical trials for its efficacy, safety, and immunogenicity compared to OPDIVO® (nivolumab) in treating melanoma. ## Drug Information ABP 206 is administered intravenously over a period of 30 or 60 minutes, typically every 4 weeks (Q4W) for treatment durations ranging from 12 to 24 months, depending on the specific trial protocol. As a biosimilar to nivolumab, it functions as a PD-1 inhibitor, helping the immune system fight cancer cells by blocking the PD-1 pathway that cancer cells use to evade immune detection. ## Clinical Trials There are multiple ongoing clinical trials evaluating ABP 206: 1. A Phase 3 randomized, double-blind study comparing ABP 206 with nivolumab in subjects with treatment-naïve unresectable or metastatic melanoma. This trial is currently recruiting patients and is sponsored by Amgen. 2. A Phase 3 study investigating the pharmacokinetic similarity and efficacy of ABP 206 compared with nivolumab in subjects with resected advanced melanoma in the adjuvant setting. This trial was recruiting but is now active and no longer recruiting as of November 2024. In these trials, eligible subjects are typically randomized to receive either ABP 206 or nivolumab (FDA-licensed or EU-authorized versions). Treatment continues until disease progression, unacceptable toxicity, or subject withdrawal of consent, with maximum treatment durations of 12-24 months. ## Development Status As of May 2025, ABP 206 remains in Phase 3 clinical development for melanoma treatment. The trials are expected to be completed between late 2025 and early 2026, with one trial having a primary completion date of October 4, 2025, and another with a completion date of December 31, 2025.

Other names

nivolumab biosimilarAmgen nivolumab biosimilar