Posted by Michael Wonder on 01 Mar 2026
EMA CHMP recommends EU approval of Henlius’ pertuzumab biosimilar HLX11
27 February 2026 - Shanghai Henlius Biotech announced that the CHMP of the EMA has adopted a positive opinion recommending the granting of marketing authorisation for HLX11 (Poherdy), a biosimilar candidate to Perjeta (pertuzumab) independently developed by Henlius.
The positive opinion recommends approval of HLX11 for all indications approved for the reference product in the European Union, covering HER2 positive early and metastatic breast cancer.
