Amneal Reports Positive Phase 3 Results for XOLAIR® Biosimilar ADL-018 In Chronic Spontaneous Urticaria (CSU) Trial

Amneal Pharmaceuticals, Inc. announced promising topline results from a confirmatory clinical trial for ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences. The randomized, double-blind study enrolled 600 patients suffering from Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU), conditions that persist despite antihistamine use. The trial successfully met both its primary and secondary endpoints, demonstrating therapeutic equivalence and a comparable safety profile between ADL-018 and XOLAIR®.

“We are pleased with the positive Phase 3 results for ADL-018, which represents an important step towards making a biosimilar to XOLAIR® available to U.S. patients. Pending FDA approval, we believe this will be a key addition to our biosimilars portfolio and part of our broader strategy to commercialize six biosimilars across eight product presentations by 2027,” said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology at Amneal Pharmaceuticals. 

Omalizumab, the biologic target of the biosimilar, is used to treat several allergic conditions, including severe asthma and CSU. In the trial, participants received 150 mg or 300 mg subcutaneous doses every four weeks over 24 weeks. The efficacy evaluation focused on a reduction in weekly itch severity score (ISS7) at Week 12 in patients who received the 300 mg dose, confirming that ADL-018 performs equivalently to the reference drug.

Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences, stated, “This marks a positive advancement for Kashiv’s growing biosimilar pipeline in addition to its current portfolio of RELEUKO® (filgrastim-ayow) and FYLNETRA® (pegfilgrastim-pbbk). We look forward to collaborating with regulatory authorities to make this treatment available to patients. Kashiv is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. We remain focused on delivering cost-effective, high-quality therapies to improve patient outcomes globally, working with commercial partners such as Amneal,” 

Kashiv BioSciences plans to submit a Biologics License Application (BLA) for ADL-018 to the U.S. FDA in Q4 2025. Amneal holds exclusive commercialization rights for the biosimilar in the U.S., contingent on regulatory approval. The market opportunity is significant, with U.S. sales for XOLAIR® reaching approximately $3.9 billion as of April 2025, underscoring the commercial potential of the biosimilar.