On 4 July 2025, The Bio reported that Korea’s Ministry of Food and Drug Safety has approved Celltrion’s Phase 3 clinical trial plan (IND) for CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab).  The trial will 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.

In December 2024, Celltrion announced that the US FDA approved its IND application for a global Phase 3 clinical trial of CT-P44, which followed its European IND submission and entry into the global Phase 3 trial in November 2024.

Shanghai Henlius 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 20 May 2025, Johnson & Johnson (J&J) announced that the US FDA has voted (6-2) in favour of the benefit-risk profile of single-agent Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM).  J&J submitted its application to the US FDA for approval of this indication in November 2024.

On 7 April 2025, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma (NDMM) regardless of transplant eligibility.  The indication expansion was recommended by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in February this year.

The EC approved the same indication in October 2024, however, only for patients who are eligible for an autologous stem cell transplant (ASCT).  The new approval removes that limitation.

There are a number of daratumumab biosimilars currently under development.  In February 2025, Shanghai Henlius announced that it has entered into a licence agreement with Dr. Reddy’s for HLX15, biosimilar to Darzalex® and Darzalex Faspro® (daratumumab and hyaluronidase-fihi).  In December 2024, Celltrion announced that the US FDA approved its Investigational New Drug (IND) application for a global Phase 3 clinical trial of its daratumumab biosimilar, CT-P44, which followed its European IND submission and entry into the global phase 3 trial procedure in November 2024.

At its February 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended expanded therapeutic indications for 16 medicines, including the following six biopharmaceuticals.

The CHMP adopted a positive opinion for an extended indication of Janssen’s Stelara® (ustekinumab) to children with Crohn’s disease weighing at least 40 kg.  The new indication will apply to Stelara® concentrate for solution for infusion and solution for injection in vial or pre-filled syringe.

Janssen also received positive CHMP opinions for Darzalex® (daratumumab), with the removal of a limitation that adult patients with newly diagnosed multiple myeloma to be treated must be “eligible for autologous stem cell transplant”, and Tremfya® (guselkumab), to include treatment of adults with ulcerative colitis.

AstraZeneca’s Imfinzi® (durvalumab) has received a positive recommendation for the new indication of treating adults with resectable NSCLC at high risk of recurrence.

The CHMP also adopted positive opinions for indication expansions to:

• Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan), to include treatment of adults with unresectable or metastatic HR-positive HER2-low or -ultralow breast cancer; and
• Roche’s Columvi® (glofitamab), to include treatment of adults with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified who are ineligible for autologous stem cell transplant.

In addition, after re-examining its initial opinion at MSD’s request, the CHMP confirmed its positive recommendation for an expanded indication for MSD’s Keytruda® (pembrolizumab) to include patients with unresectable non-epithelioid malignant pleural mesothelioma.  The positive recommendation was initially adopted in November 2024.

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the month of January.  Among the applications for new medicines to be reviewed is GSK’s Blenrep® (belantamab mafodotin) for the treatment of patients with multiple myeloma that has returned or did not respond to treatment.

Meanwhile, AbbVie’s Elahere® (mirvetuximab soravtansine) has been accepted for review for the treatment for adult patients with a specific type of ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy.  Elahere® received EU approval for this indication in November 2024.

Applications for new indications of biopharmaceuticals currently under evaluation by the TGA include:

• AstraZeneca’s Imfinzi® (durvalumab) for muscle invasive bladder cancer. Imfinzi® is already also under review by the TGA for the treatment of patients with limited-stage small cell lung cancer;
• Takeda’s Adcetris® (brentuximab vedotin) for the treatment of adult patients with previously untreated Hodgkin Lymphoma, in combination with other anti-cancer drugs;
• Janssen’s Darzalex SC® (daratumumab) for the treatment of patients with newly-diagnosed multiple myeloma who are ineligible for a stem cell transplant, and high-risk smouldering multiple myeloma; and
• Janssen’s Tremfya® (guselkumab) for the treatment of children aged 6 years and older with moderate to severe plaque psoriasis who are eligible for systemic (whole-body) therapy or phototherapy (ultraviolet light therapy.

On 6 February 2025, Shanghai Henlius announced that it has entered into a licence agreement with Dr. Reddy’s for HLX15, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab) and Darzalex Faspro® (daratumumab and hyaluronidase-fihi), used in treating multiple myeloma.  The agreement grants Dr Reddy’s exclusive commercialisation rights for HLX15, covering both subcutaneous and intravenous formulations, across 42 European countries and the United States.  Henlius is responsible for development, manufacturing and supply, and will receive up to US$131.6 million, including US$33 million upfront and additional milestone payments and royalties based on annual net sales of 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®.

Worldwide annual net sales of Darzalex® (daratumumab) in 2024 totalled US$11.7 billion.

On 22 January 2025, Johnson & Johnson (J&J) reported its results for Q4 2024, which saw sales growth of 5.3% to $22.5B.

On the same day, Genmab announced that worldwide annual net sales of Darzalex® (daratumumab) for 2024, as reported by J&J, totalled USD11.7 billion.  US sales accounted for more than half of this total, reaching USD6.6 billion.  Genmab receives royalties on the worldwide net sales of Darzalex® (IV and SC), under its exclusive worldwide licence to Janssen to develop, manufacture and commercialise daratumumab.

J&J reports that it achieved several significant regulatory milestones in Q4 2024 across the EU and US.  This includes the European approval for several new indications of J&J biologics, such as Darzalex® SC based quadruplet regimen for multiple myeloma (October 2024), and Rybrevant® (amivantamab) in combination with Lazcluze® (lazertinib) for non-small cell lung cancer (December 2024).  J&J also submitted an application in the EU for approval of Darzalex® SC for high-risk smouldering multiple myeloma (November 2024).

In the US, J&J submitted an application for approval of a new indication of Darzalex Faspro® (daratumumab and hyaluronidase-hj) for high-risk smouldering multiple myeloma (November 2024), and received Breakthrough Therapy designation (BTD) for nipocalimab for the treatment of adults living with moderate-to-severe Sjögren’s disease (November 2024).  J&J also sought FDA approval for a subcutaneous induction regimen of Tremfya® (guselkumab) for ulcerative colitis (November 2024).

On 27 December 2024, Celltrion announced that the US FDA has approved its Investigational New Drug (IND) application for a global Phase 3 clinical trial of CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab).  According to Celltrion, the trial will involve 486 patients with refractory or relapsed multiple myeloma, and will evaluate similarity in pharmacokinetics, efficacy, and safety between Darzalex® and CT-P44.

This follows Celltrion’s announcement of its European IND submission for CT-P44 and entry into the global phase 3 trial procedure in November 2024.

On 8 December 2024, Johnson & Johnson (J&J) announced data showing that Darzalex Faspro® (daratumumab and hyaluronidase-fihj) )-based regimens improve overall and sustained minimal residual disease negativity rates and progression-free survival in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.  The results were demonstrated in an analysis of the Phase 3 CEPHEUS study (NCT03652064) and a post hoc analysis of clinically relevant subgroups in the Phase 3 AURIGA study (NCT03901963).

On the same day, J&J also announced new frontline data featuring Tecvayli® (teclistamab-cqyv) from two investigational studies, MajesTEC-5 (NCT05695508) and MajesTEC-4 (NCT05243797).

In the MajesTEC-5 study, patients with transplant-eligible newly diagnosed multiple myeloma (NDMM) were treated with Tecvayli® in combination with Darzalex Faspro® (daratumumab and hyaluronidase-fihj), lenalidomide and dexamethasone or Darzalex Faspro®, bortezomib, lenalidomide and dexamethasone.  All patients who were evaluated for MRD negativity after cycle 3 of induction therapy achieved MRD negativity (10^-5) and maintained through cycle 6.

Results from the MajesTEC-4 study demonstrated the potential for Tecvayli® to be administered as a maintenance therapy following autologous stem cell transplant (ASCT).

Earlier this year, the US FDA approved J&J’s supplemental Biologics License Application (sBLA) to use Tecvayli® with a reduced dosing frequency for cancer patients (February 2024).

On 8 December 2024, Johnson & Johnson (J&J) announced data from the Phase 3 AQUILA study (NCT03301220) showing a 51 percent reduction in the risk of progression to active multiple myeloma for patients with high-risk smoldering multiple myeloma when treated with Darzalex Faspro® (daratumumab and hyaluronidase-fihj).

This follows J&J’s announcement in November 2024 that it has submitted applications to the US FDA and European Medicines Agency (EMA) for approval of a new indication for Darzalex Faspro® in the US and Darzalex® (daratummab) subcutaneous (SC) formulation in the EU, as monotherapy for high-risk smouldering multiple myeloma.