Amneal reports positive phase 3 results for XOLAIR biosimilar

BRIDGEWATER, N.J. - Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX), a pharmaceutical company with a market capitalization of $2.55 billion and revenue growth of ~13% over the last twelve months, announced positive topline results from a confirmatory clinical trial evaluating ADL-018, a proposed biosimilar to Novartis’s XOLAIR (omalizumab), developed by Kashiv BioSciences, LLC. According to InvestingPro data, the company shows promising growth potential, with analysts expecting improved profitability this year.

The randomized, double-blind study assessed the efficacy, safety, and immunogenicity of ADL-018 compared to XOLAIR in 600 patients with Chronic Idiopathic Urticaria or Chronic Spontaneous Urticaria who remained symptomatic despite antihistamine treatment.

According to the company, the trial achieved its primary and secondary endpoints by establishing therapeutic equivalence and comparable safety between ADL-018 and the reference product. The primary efficacy measure was the change from baseline in weekly itch severity score at Week 12.

"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," said Sean McGowan, Senior Vice President, Biosimilars and Branded Oncology at Amneal Pharmaceuticals.

Kashiv BioSciences expects to submit a Biologics License Application to the U.S. Food and Drug Administration in the fourth quarter of 2025. Amneal holds exclusive U.S. commercialization rights for the product, pending regulatory approval.

Omalizumab is indicated for treating severe allergic asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria.

U.S. annual sales for XOLAIR totaled approximately $3.9 billion for the 12 months ending April 2025, according to IQVIA data cited in the company’s press release.

The biosimilar would be part of Amneal’s strategy to commercialize six biosimilars across eight product presentations by 2027.

In other recent news, Amneal Pharmaceuticals reported its first-quarter 2025 earnings, surpassing analysts’ expectations with an adjusted EPS of $0.21, compared to the forecasted $0.15. However, the company’s revenue came in at $695 million, slightly below the anticipated $726.49 million. Amneal’s gross margin improved to 43.1%, highlighting its focus on operational efficiencies. The U.S. Food and Drug Administration has approved Amneal’s Brekiya autoinjector for migraines, marking it as the first DHE autoinjector available for such treatment. Additionally, the FDA approved Amneal’s prednisolone acetate eye drops, with a commercial launch expected in the third quarter of 2025. Goldman Sachs initiated coverage on Amneal Pharmaceuticals with a Neutral rating, highlighting the company’s strong product pipeline as a key growth driver. Analysts expect Amneal’s generics segment to exceed consensus estimates by approximately 13% in fiscal year 2027, driven by biosimilar and sterile injectable launches. These developments reflect Amneal’s strategic focus on high-value products and its robust pipeline.

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