On 26 November 2024, Celltrion’s Omlyclo®, biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab) was approved in Australia. Omlyclo® is the first omalizumab biosimilar approved in Australia.
Omylclo® was approved in Australia for two presentations:
Whilst there are no Australian patent proceedings on foot to date regarding omalizumab, Novartis/Genentech and Celltrion are involved in UPC proceedings regarding alleged infringement of EP3805248 relating to an omalizumab formulation. In September 2024, the Dusseldorf Local Division of the UPC rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion.
Celltrion’s Omlyclo® is approved in Europe (May 2024), the UK (July 2024) and South Korea (June 2024). Celltrion submitted an aBLA in the US for its omalizumab biosimilar in March 2024 and in Canada in December 2023.
KashivBiosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.