On 27 March 2026, Johnson & Johnson announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Darzalex® (daratumumab) subcutaneous (SC) formulation. The update enables patients with multiple myeloma (or their caregivers) to administer Darzalex® from the fifth dose, if considered appropriate by their healthcare provider and following proper training. This makes Darzalex® the first oncology injectable approved in Europe for self-administration.
J&J’s Daratumumab SC (known as Darzalex® SC in the EU and Darzalex Faspro® in the US) was first approved in the EU in 2020. It is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s Enhanze® drug delivery technology. Most recently, in July 2025, the European Commission approved an indication extension for Darzalex® SC as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma
The first approval for a daratumumab biosimilar was granted in Russia to Biocad in August 2025. Daratumumab biosimilars are under development by Celltrion (CT-P44), Henlius (HLX15/HLX15-SC), and CSPC. In February 2025, Henlius announced it had entered into a licence agreement with Dr Reddy’s for commercialisation of both SC and IV formulations of HLX15, across 42 European countries and the United States.