On 30 April 2025, Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an update to the European Union (EU) label for Phesgo® to allow administration outside of a clinical setting, such as in a person’s home, by a healthcare professional. Phesgo® is a subcutaneous fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab), used to treat human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Earlier this month, in its 2025 first quarter earnings call, Roche described its biosimilar exposure for its Perjeta® (pertuzumab) as “relatively limited” and “not a threat that we’re super worried about right now,” considering the lack of potential competitors in late-stage development or filing. Roche believes that the most-advanced pertuzumab biosimilar, Henlius’ HLX11, is unlikely to enter the market until at least late 2027.
HLX11 is currently under consideration for regulatory approval in the EU (March 2025), US (February 2025) and China (December 2024). In June 2022, Henlius entered into a licence agreement with Organon regarding HLX11 (and HLX14), under which Organon has exclusive global commercialisation rights to the biosimilars for all countries except China, Hong Kong, Macau and Taiwan.