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Roche Revises Expectations of Biosimilar Competition to Pertuzumab and Omalizumab

Jul 24, 2025

Roche’s 2025 second-quarter earnings call included disclosure that it now expects biosimilar competition to Perjeta® (pertuzumab) and Xolair® (omalizumab) in 2026, sooner than previously anticipated.

In its previous quarterly earnings call in April 2025, Roche had said that it did not expect competition to Perjeta® until late 2027.  The biosimilar expected to provide the first serious competition remains Henlius/Organon’s HLX11, which is being considered for approval in Europe, the US, and China.  Organon’s own earnings call is scheduled for 5 August 2025.  Other pertuzumab biosimilars have been approved in India (Zydus and Intas) and Russia (Biocad).

Celltrion’s Omlyclo® (omalizumab) is already approved in the EU (May 2024), Korea (June 2024), Australia (November 2024), Canada (December 2024), the US (March 2025) and New Zealand (April 2025).  It has been the subject of legal disputes in at least the UK and Europe.