Just ahead of Alvotech publishing its annual results, the biosimilars developer has revealed a first filing for its AVT23 proposed biosimilar to Xolair (omalizumab). In conjunction with partner Advanz Pharma, the firm has received confirmation from the UK Medicines and Healthcare Products Regulatory Agency that the omalizumab candidate has been accepted for review by the MHRA.
Alvotech And Advanz Make First Omalizumab Filing
Partners Submit Kashiv-Developed Xolair Biosimilar To UK’s MHRA
Alvotech and Advanz have announced a UK MHRA filing acceptance for their partnered AVT23 proposed biosimilar to Xolair (omalizumab).

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Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.
Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.
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