Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilar Deals 2025
Biosimilars Deals 2023
Biosimilars Deals 2024
Chris Vindurampulle
Diversity
Helen Macpherson
Intranet
Kimberley Evans
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
Paul Johns
PipCast®
PTE
Trade Marks
Webinars

New Indication Alert: Janssen’s Daratumumab EU Approved for SMM

Jul 23, 2025

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®.