On 23 July 2025, Janssen announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation (SC) as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma. Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology.
In November 2024, Janssen’s parent company, Johnson & Johnson, submitted its regulatory applications for the indication extension in the EU (Darzalex® SC) and in the US (Darzalex Faspro® SC, daratumumab and hyaluronidase-fihj). The US FDA voted in favour (6-2) of Darzalex Faspro®’s benefit-risk profile in May 2025.
In July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety approved Celltrion’s Phase 3 clinical trial plan (IND) for its daratumumab biosimilar, CT-P44, to evaluate and compare the efficacy and safety of Darzalex® and CT-P44 over a two-year period in 486 patients with relapsed or refractory multiple myeloma.
Shanghai Henlius also has a daratumumab biosimilar in development, announcing in February 2025 that it entered into a licence agreement with Dr. Reddy’s for HLX15. In June 2024, Henlius announced the completion of Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.