On 3 April 2025, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved by New Zealand’s Medsafe for the same indications as its reference product.
Omlyclo® is the first omalizumab biosimilar approved in New Zealand. It was also the first omalizumab biosimilar to be approved in the US (March 2025), Canada (December 2024), Australia (November 2024), the UK (July 2024), South Korea (June 2024), and Europe (May 2024).
Alvotech/Kashiv Biosciences, Aurobindo, Teva and Glenmark are reported to have omalizumab biosimilars under development.
In January 2025, a UK Court denied Celltrion’s application to revoke Genentech/Novartis’ UK omalizumab formulation patent (EP 3805248), finding it was valid and infringed by Celltrion.