Amneal Pharmaceuticals announced positive topline results from a Phase 3 trial of ADL-018, a biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences. The study met its primary and secondary endpoints, demonstrating therapeutic equivalence and comparable safety between ADL-018 and XOLAIR® in patients with chronic idiopathic urticaria (CIU) or chronic spontaneous urticaria (CSU). Amneal holds exclusive U.S. commercialization rights, with a BLA filing anticipated in Q4 2025.
This positive Phase 3 data is a significant development for Amneal, potentially positioning them to compete in the substantial $3.9 billion U.S. omalizumab market. A successful launch of ADL-018 could be a major growth driver for Amneal, diversifying its portfolio and enhancing its position in the biosimilars space. It also provides patients with a potential alternative treatment option for CIU/CSU, potentially increasing access and affordability.
The Phase 3 study involved 600 patients, with efficacy and safety evaluations conducted on 400 patients receiving the 300 mg dose. The primary endpoint, change from baseline in the weekly itch severity score (ISS7) at Week 12, demonstrated equivalence between ADL-018 and XOLAIR®. This positive outcome supports the potential for regulatory approval and subsequent market entry.
This successful trial paves the way for Amneal to potentially introduce a biosimilar competitor to XOLAIR® in the U.S. market. If approved, ADL-018 could reshape the treatment landscape for CIU/CSU, offering patients a more affordable therapeutic option and increasing competition within the market. This development reinforces Amneal’s strategic focus on biosimilars as a key growth area, potentially generating significant revenue and solidifying its position in the pharmaceutical industry.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
