On 26 May 2026, Shanghai Henlius announced that the first patient has been dosed in its phase 1 international multicentre clinical trial of HLX15-SC (daratumumab and hyaluronidase-fihj), biosimilar to J&J’s Darzalex Faspro®, for the treatment of multiple myeloma.

Shanghai Henlius’ Investigational New Drug (IND) application for the phase 1 clinical trial of HLX15-SC was approved by the FDA in February 2026, shortly after the trial was approved in China.

Henlius is also developing an IV form of HLX15, having completed a successful Phase 1 clinical trial of HLX15-IV against US, EU and CN sourced Darzalex® (daratumumab) in June 2024.

Both SC and IV forms of HLX15 will be commercialised by Dr Reddy’s in Europe and the US under the terms of a licence agreement announced in February 2025.

The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025 for Daratumia®.  Daratumumab biosimilars are under development, including by CSPC Pharmaceutical Group, which obtained approval from the NMPA in December 2025 to conduct clinical trials in China of its Daratumumab Injection, and Celltrion, whose Phase 3 clinical trial plan for CT-P44 (daratumumab) was approved in Europe in September 2025.

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.

On 5 March 2026, J&J announced the US approval of Tecvayli® (teclistamab-cqyv) in combination with Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of relapsed or refractory multiple myeloma (RRMM) as a second line treatment.

This approval was based on the Phase 3 MajesTEC-3 study, which evaluated the safety and efficacy of teclistamab and daratumumab in RRMM patients who had received at least one prior line of therapy, against the one of the following combinations:

• daratumumab, dexamethasone and pomalidomide or
• daratumumab, dexamethasone, bortezomib

The Tecvayli®/Darzalex Faspro® combination demonstrated the best patient outcomes, showing an 83% reduction in the relative risk of progression or death when compared with standard treatment.

Approval was granted 55 days after filing, following the selection of the teclistamab’s sBLA under the Commissioner’s National Priority Voucher Pilot Program.

Daratumumab biosimilars are under development by Celltrion, Henlius, and CSPC.  Globally, the first approval for a daratumumab biosimilar was granted in Russia to Biocad in August 2025.  There is no evidence that any teclistamab biosimilars have been submitted for regulatory review or approval.

On 26 February 2026, Celltrion reported that it plans to expand its biosimilar lineup to 18 products by 2030 with seven candidates that have either entered clinical development or for which investigational new drug applications are being prepared.  Celltrion’s disclosed programmes include CT-P53 biosimilar to Ocrevus (ocrelizumab), CT-P55 biosimilar to Cosentyx (secukinumab) and CT-P52 biosimilar to Taltz (ixekizumab) in autoimmune diseases, as well as cancer therapies CT-P51 biosimilar to Keytruda (pembrolizumab) and CT-P44 biosimilar to Darzalex (daratumumab).

This announcement adds further detail to Celltrion’s commercialisation plans reported in January 2026.

On 16 February 2026, Shanghai Henlius Biotech announced it has obtained Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its subcutaneous daratumumab biosimilar, HLX15-SC.  This will allow Henlius to undertake a phase I clinical study of HLX15-SC, biosimilar to J&J’s Darzalex Faspro® (daratumumab and hyaluronidase-fihj), for the first-line treatment of multiple myeloma.

The FDA clearance follows Henlius’ announcement on 12 February 2026 that China’s National Medical Products Administration (NMPA) approved a Phase 1 trial of HLX15-SC.

Henlius is also developing an IV form of HLX15, having completed a Phase 1 clinical trial of HLX15-IV in June 2024.  The trial demonstrated similar pharmacokinetic characteristics, comparable safety and immunogenicity profiles of HLX15-IV to the US, EU and CN-sourced Darzalex® (daratumumab).

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.

Henlius’ development appears to be trailing that of Celltrion.  In September 2025, the European Medicines Agency approved Celltrion’s IND application for its global Phase 3 clinical trial of CT-P44 (daratumumab), following approval of its US IND submission in December 2024.  In December 2025, CSPC Pharmaceutical Group obtained approval from the NMPA to conduct clinical trials in China of its Daratumumab Injection.

In August 2025, BIOCAD announced that the Russian Ministry of Health had approved its Daratumia®.  This was the first reported regulatory approval for a daratumumab biosimilar worldwide.

On 12 February 2026, Zhitong Finance reported that Shanghai Henlius Biotech has obtained approval from China’s National Medical Products Administration (NMPA) for a Phase 1 trial of its subcutaneous daratumumab biosimilar, HLX15-SC.

This follows Henlius’ completion of a Phase 1 clinical trial for the IV formulation of HLX15 in June 2024.  That trial demonstrated similar pharmacokinetic characteristics and comparable safety and immunogenicity profiles of HLX15 to the US, EU and CN-sourced reference product, J&J’s Darzalex® (daratumumab).

In February 2025, Henlius announced that it had entered into a licence agreement with Dr Reddy’s for commercialisation of HLX15, covering both subcutaneous and intravenous formulations, across 42 European countries and the United States.

The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025, with approval by the Russian Ministry of Health of Daratumia®.  There are also other daratumumab biosimilars under development.  In December 2025, CSPC Pharmaceutical Group obtained approval from the NMPA to conduct clinical trials in China of its Daratumumab Injection.  In September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) approved Celltrion’s Phase 3 clinical trial plan (IND) for its daratumumab biosimilar, CT-P44.

On 23 December 2025, CSPC Pharmaceutical Group Limited announced that it has obtained approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials in China of its Daratumumab Injection, biosimilar to Johnson & Johnson’s Darzalex®.

The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025.  According to BIOCAD, the Russian Ministry of Health approved its Daratumia®, the first daratumumab biosimilar approved in the country.

There are also a number of other daratumumab biosimilars currently under development.  In June 2024, Shanghai 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®.  In February 2025, Henlius announced that it had entered into a licence agreement with Dr. Reddy’s for HLX15.

In September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) approved Celltrion’s Phase 3 clinical trial plan (IND) for its daratumumab biosimilar, CT-P44.

On 1 September 2025, Korea Biomedical Review reported that the European Medicines Agency (EMA) has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), in relapsed or refractory multiple myeloma.  Celltrion submitted its IND to the EMA in November 2024.

In July 2025, Celltrion announced that Korea’s Ministry of Food and Drug Safety approved its IND application for its global Phase 3 clinical trial of CT-P44, which followed approval of its US IND submission in December 2024.

In August 2025, BIOCAD announced that the Russian Ministry of Health had approved its Daratumia®, the first daratumumab biosimilar approved in the country.  This is the first reported regulatory approval for a daratumumab biosimilar worldwide.

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®.

On 22 August 2025, BIOCAD announced that the Russian Ministry of Health has approved Daratumia®, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), as the first daratumumab biosimilar approved in the country.  This is the first reported regulatory approval for a daratumumab biosimilar that has been identified to date worldwide.

There are a number of daratumumab biosimilars currently in development.  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 completed Phase 1 clinical trials of HLX15, demonstrating that HLX15 has similar pharmacokinetic characteristics, and comparable safety and immunogenicity profiles to Darzalex®.

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®.