At its September 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three new biologics, each of which was designated as an orphan medicine during development, and recommended indication extensions for five.

The new biologics are AbbVie’s antibody drug conjugate Elahere® (mirvetusimab soravtansine) for treatment of adults with ovarian, fallopian tube or primary peritoneal cancer (which received FDA approval in March 2024); Pfizer’s Hympavzi® (marstacimab) for bleeding episodes in patients aged 12 years and older with sever haemophilia A or B; and Henlius/Intas’ Hetronifly® (serplulimab) for first‑line treatment of adult patients with extensive‑stage small cell lung cancer (ES‑SCLC).

Hetronifly® (serplulimab) will reportedly be commercialised by Intas through its subsidiary, Accord Healthcare, across more than 30 countries in Europe.  Serplulimab has previously been launched as HANSIZHUANG in China, Indonesia, Cambodia and Thailand.

The five recommended indication expansions for biologics are:

• Janssen’s Darzalex® (daratumumab), in combination with bortezomib, lenalidomide and dexamethasone for adults with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant;
• Sanofi’s Dupixent® (dupilumab) for eosinophilic esophagitis in adults, adolescents and children aged 1 year and older who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy;
• AstraZeneca’s Fasenra® (benralizumab) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis;
• Novo Nordisk’s Esperoct® (turoctocog alfa pegol) for treatment and prophylaxis of bleeding in all age groups with haemophilia A (congenital factor VIII deficiency); and
• MSD’s Keytruda® (pembrolizumab) for two cancer indications: (i) in combination with carboplatin and paclitaxel, followed by Keytruda® as a single agent, for first-line treatment of adults with primary advanced or recurrent endometrial carcinoma who are candidates for systemic therapy; and (ii) in combination with chemoradiotherapy (CRT) for FIGO (International Federation of Gynaecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.

In addition, two aflibercept biosimilars received positive opinions at CHMP’s September 2024 meeting, as reported here.

On 30 July 2024, Johnson & Johnson (J&J) announced that the FDA approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone (D-VRd) for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.

J&J submitted its sBLA to the FDA for approval of Darzalex Faspro® in January this year.  In March 2024, J&J submitted an application to the European Medicines Agency for Darzalex® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with multiple myeloma.

Last month, Shanghai Henlius announced the completion of phase 1 clinical trials of its daratumumab biosimilar, HLX15.

Shanghai Henlius Biotech has announced the completion of phase 1 clinical trials of HLX15, biosimilar to Janssen’s Darzalex® (daratumumab).  The studies demonstrated that HLX15 has similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US, EU, and CN sourced Darzalex®. 

In December 2021, Xbrane Biopharma announced it was developing a biosimilar to Darzalex® (daratumumab). 

On 5 February 2024, Glaxo Smith Kline (GSK) announced results from an interim analysis of its DREAMM-7 phase III trial.  The trial compared two treatment combinations, namely: 

• Blenrep® Combination: Blenrep® (belantamab mafodotin) +  BorDex® (bortezomib plus dexamethasone); and 
• Daratumumab combination: daratumumab + BorDex® (bortezomib plus dexamethasone) 

The Blenrep® Combination showed: a) 59% further reduction in risk of disease progression or death, b) 23.2 more months of median progression-free survival, and c) 43% reduction in risk of death.   

Johnson & Johnson announced it submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for induction and consolidation treatment, and with lenalidomide for maintenance treatment of adult patients who are newly diagnosed with multiple myeloma (NDMM) and are eligible for autologous stem cell transplant.

In December 2021, Xbrane Biopharma announced it was developing a biosimilar to Darzalex® (daratumumab).

Xbrane Biopharma announced it is developing two new biosimilar candidates referencing Keytruda® (pembrolizumab) and Darzalex® (daratumumab).

AU’s PBAC published the outcomes from its July 2021 meeting. PBAC recommended listing:

• Pfizer’s Abrilada® (50mg/mL adalimumab biosimilar) in 20mg/0.4mL syringe, 40mg/0.8mL syringe and 40mg/0.8mL pen for all indications as Humira®.
• Janssen’s Darzalex SC® (daratumumab) for all indications for which the intravenous form of daratumumab is currently listed.
• Pfizer’s Enbrel® (etanercept) in 50mg/1mL single use dose-dispenser cartridges under the same conditions as existing listings for etanercept.
• BMS’ Opdivo® (nivolumab) for the treatment of patients with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression following treatment with a fluoropyrimidine and platinum (FP)-based chemotherapy regimen.