On 6 October 2026, Celltrion announced the US launch of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab). Omlyclo® is the first omalizumab biosimilar on the US market and is available in three dosage forms: 75 mg, 150 mg and 300 mg.
Omlyclo® was launched in the US at a wholesale acquisition cost (WAC) approximately 15% lower than that for the reference product, Xolair®. It is listed as a preferred drug in the private insurance prescription book of Optum, a major US Pharmacy Benefit Manager (PBM). According to Celltrion, it is also in negotiations with other PBMs.
Omlyclo® was first approved in the US in March 2025, in 75 mg/0.5ml and 150mg/ml PFS forms, with full interchangeable status. The 300 mg formulation was FDA approved in December 2025.
The European launch of Omlyclo® in 75 mg and 150 mg dosage forms commenced in September 2025 and was completed in November 2025. The high dose (300 mg) dosage form was launched in Europe in August 2026. Omlyclo® to date remains the only omalizumab biosimilar approved in the EU, with Celltrion receiving EU market authorisation for its 75 mg/0.5 mL and 150 mg/1 mL PFS formulations in May 2024, and approval for the 300 mg formulation in November 2025
Omalizumab biosimilars in development include Kashiv BioSciences/Alvotech’s ADL-018/AVT23, with an application for ADL-018 accepted for review by Health Canada in June 2026 and marketing applications for AVT23 accepted by the UK’s MHRA in March 2025 and the European Medicines Agency in October 2025. Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018/AVT23 in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand. Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).
Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026. Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.