At the JP Morgan Annual Healthcare conference on 13 January 2025, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) in Phase 3 trials. The Phase 3 study (NCT06700343), which begins enrolment this month in the US, is aimed at demonstrating pharmacokinetic and pharmacodynamic similarity between ABP 692 and Genentech’s Ocrevus® (ocrelizumab) in patients with relapsing, remitting multiple sclerosis.
Celltrion also has an ocrelizumab biosimilar in development, announcing in August 2023 that the European Medicines Agency (EMA) had partially approved its Phase 3 IND for CT-P53 (ocrelizumab). Its study (NCT05906992), to be conducted in Poland, is currently recruiting.
Amgen has two further biosimilars in Phase 3 trials: pembrolizumab (Ph 3 in nsNSCLC initiated May 2024 for ABP 234) and nivolumab (patients enrolled in a study evaluating pharmacokinetic similarity of ABP 206 compared with BMS’ Opdivo® (nivolumab) in Q2/2024).
Amgen is expecting to launch its Wezlana®/ustekinumab (biosimilar to J&J/Janssen’s Stelara®) in the US in Q1/2025 and is planning a US-launch for Bkemv®/eculizumab (biosimilar to Alexion’s Soliris®) in Q2 2025. Bkemv®’s US launch is subject to a settlement reached by Amgen and Alexion in May 2020.