Alvotech has signed an exclusive licensing agreement with Kashiv Biosciences for AVT23 to develop a biosimilar to Roche and Novartis’ Xolair (omalizumab).

Xolair is a monoclonal antibody that inhibits immunoglobulin E (IgE), which was developed by Novartis and licensed by Roche. Since it was first approved for the treatment of allergic asthma, the drug has achieved blockbuster status. Xolair generated $716m and SFr1.03bn ($1.4bn) in sales in H1 2023, for Novartis and Roche, respectively. In 2018, it received a Breakthrough therapy designation for the preventing severe allergic reactions following accidental exposure to one or more foods in people with allergies.

Biosimilars are forecasted to reduce Xolair sales from a projected $3.7bn in total sales in 2023 to $1.6bn in 2029, as per GlobalData.

GlobalData is the parent company of Pharmaceutical Technology.

As per the agreement, Kashiv will receive an upfront payment and will be eligible for future milestone payments and royalties following the successful development and approval of AVT23. The drug is currently in Phase III (NCT05774639) clinical development.

Other companies that are developing Xolair include Teva Pharmaceuticals, which is studying TEV-45779 in a Phase III study (NCT04976192). GlobalData forecasts that Teva’s biosimilar will generate $128m in 2027.

In June, one of Alvotech’s biosimilars, AVT02, was rejected for the third time by the US Food and Drug Administration. All of the rejections were due to deficiencies seen at one of the company’s manufacturing facilities in Reykjavik, Iceland.

In recent years, Alvotech has been pushing to bolster its biosimilar portfolio. In May, Alvotech also partnered with Advanz Pharma to include five additional biosimilar candidates, including proposed biosimilars to Janssen’s Simponi (golimumab) and Takeda’s Entyvio (vedolizumab), and three early-stage, undisclosed biosimilars.

Other biosimilars in Alvotech’s pipeline include ATV04, a biosimilar of Janssen’s Stelara (ustekinumab). In total, the company is developing a pipeline of seven disclosed and three undisclosed biosimilars, as per Alvotech’s Q2 earnings report.

Correction: The second paragraph was updated to reflect the Xolair's regulatory status as a drug with a breakthrough therapy designation for preventing food allergies. A previous version said the therapy was approved to prevent food allergies.