Other Updates

On 21 December 2024, Novo Nordisk announced that US FDA has approved its Alhemo® (concizumab) injection as a once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adult and paediatric patients 12 years or age and older with haemophilia A or B with inhibitors.  Alhemo® is the first subcutaneous injection treatment of its kind for this population. 

In addition to the US, Alhemo® is currently approved in Australia, Japan, Switzerland and the EU, with specific indications varying by country. 

On 20 December 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes considered at its November 2024 meeting, recommending listing for one biosimilar, and three originator biopharmaceuticals.  

The following biosimilars were recommended for listing on the Pharmaceutical Benefits Scheme (PBS): 

• Sandoz’s Wyost®, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab), for osteoporosis, giant cell tumour of bone, and bone metastases 

• Celltrion’s Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), for severe chronic plaque psoriasis, severe psoriatic arthritis, Crohn’s disease, complex refractory fistulising Crohn disease, and moderate to severe ulcerative colitis. 

Among the originator biopharmaceuticals, Bayer secured a recommendation for its Eylea® (aflibercept) indication expansion for diabetic macular oedema and subfoveal choroidal neovascularisation secondary to age-related macular degeneration.  Novo Nordisk’s Ozempic® (semaglutide) also received a positive recommendation for type 2 diabetes mellitus, following its application for a new strength formulation.  

Several oncology treatments received positive recommendations, including Janssen’s Rybrevant® (amivantamab) for non-small cell lung cancer.  Other cancer treatments recommended include Amgen’s Blincyto® (blinatumomab) for MRD-negative B-cell precursor acute lymphoblastic leukaemia, AstraZeneca’s combination therapy Imfinzi/Lynparza® (durvalumab/olaparib) for advanced, metastatic or recurrent endometrial cancer, and Astellas Pharma’s Padcev® (enfortumab vedotin) for locally advanced or metastatic urothelial cancer. 

AbbVie’s Epkinly® (epcoritamab) received a recommendation for relapsed or refractory diffuse large B-cell lymphoma, while Novartis’ Aimovig® (erenumab) was recommended for chronic migraine.   

For hereditary angioedema, both CSL’s garadacimab and Takeda’s Takhzyro® (lanadelumab) secured positive recommendations. 

Additional recommendations were granted to BMS’s Opdivo® (nivolumab) for urothelial carcinoma, MSD’s Keytruda® (pembrolizumab) for renal cell carcinoma, and Alexion Pharmaceuticals’ Ultomiris® (ravulizumab) for Neuromyelitis Optica Spectrum Disorder.  

BeiGene’s Tevimbra® (tislelizumab) also received a positive recommendation for oesophageal squamous cell carcinoma. 

The PBAC reports that some earlier recommendations have been extended: 

• Sanofi’s Dupixent® (dupilumab) for chronic severe atopic dermatitis 

• AbbVie’s Skyrizi® (risankizumab) for Crohn disease 

 Additionally, one recommendation has been rescinded: 

• Celltrion Remsima SC® (infliximab) for rheumatoid arthritis 

On 20 December 2024, Fresenius Kabi announced that it had entered into a licensing agreement with SamChunDang Pharm (SCD) to exclusively commercialise South Korean developed SCD-411, biosimilar to Regeneron’s Eylea® (aflibercept), in the United States, Brazil, Argentina, Chile, Paraguay, Colombia, and Mexico.  SCD is responsible for the development, manufacture, and supply of SCD-411. 

This licensing deal follows news in March this year that SCD entered an exclusive distribution agreement with an unnamed distributor to supply SCD-411 in the UK, Belgium, the Netherlands, Norway, Portugal, Sweden, Greece, Ireland, and Finland.   SCD-411 was also the subject of an exclusive distribution agreement reported in November 2023, between SCD and an unnamed distributor, for supply to Austria, Germany, Italy, Spain, and Switzerland.  SCD has licensed SCD411 to Apotex for the Canadian market. 

On 19 December 2024, New Zealand’s Pharmac issued a media release requesting feedback on proposals to fund six medicines for cancer and antibiotic resistant infections from 1 April 2025, which includes: 

• BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) (in combination) for kidney cancer as a first treatment option; and 
• Pfizer’s Besponsa® (inotuzumab ozogamicin) for a type of blood cancer called acute lymphoblastic leukaemia.

The consultation period closes on 24 January 2025.  

In September 2024, Pharmac announced that Opdivo® (as monotherapy) would be fully funded for eligible people with kidney cancer from 1 November 2024.   

As previously reported, New Zealand has recently increased funding for cancer drugs, including Keytruda® (pembrolizumab).   

On 18 December 2024, Australia’s Pharmaceutical Benefits Scheme (PBS) published its agenda for the May 2025 Pharmaceutical Benefits Advisory Committee (PBAC) meeting.  

The May 2025 agenda list 8 biologics for consideration, 3 of which are listed for new PBS additions:  

In November 2024, PBAC previously published its agenda for the March 2025 meeting, which will consider 23 monoclonal antibodies, including four biosimilars. 

On 17 December 2024, Gilead Sciences announced that the US FDA has granted Breakthrough Therapy Designation (BTD) to Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy. 

Trodelvy® was previously approved in Australia for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer (September 2021). 

On 17 December 2024, Eli Lilly announced that China’s National Medical Products Administration (NMPA) has approved its donanemab-azbt Kisunla® (350 mg/20 mL every four weeks injection for IV infusion) for the treatment of early symptomatic Alzheimer’s Disease (AD) in adults.  This includes people with mild cognitive impairment as well as those with the mild dementia stage of AD who have confirmed amyloid pathology. 

It is estimated that nearly 6% of people over the age of 65 in China are currently living with AD and related dementias, with nearly 11% over the age of 65 predicted to be living with AD by 2050. 

This follows the approval of Kisunla® in the US in July 2024, Japan in September 2024 and the UK in October 2024.  

On 16 December 2024, Johnson & Johnson (J&J) announced that it submitted a supplemental Biologics Licence Application (sBLA) to the US FDA seeking the approval of Simponi® (golimumab) for the treatment of children two years and older with moderately to severely active ulcerative colitis (UC).  This would add to the already approved indication of Simponi® for the treatment of adults with moderately to severely active UC. 

This news follows Alvotech and Advanz Pharma’s announcement in November 2024 that the European Medicines Agency (EMA) has accepted their marketing authorisation application (MAA) for their AVT05, biosimilar to Simponi® (golimumab), for treatment of several chronic inflammatory diseases.  This is thought to be the first golimumab biosimilar MAA to be filed and accepted anywhere in the world. 

On 16 December 2024, GSK announced that the US FDA has granted Breakthrough Therapy Designation to Jemperli® (dostarlimab) for the treatment of patients with locally advanced mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) rectal cancer. 

Earlier this month, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Jemperli® for first line treatment (with chemotherapy) of primary advanced or recurrent endometrial cancer. 

In August 2024, Jemperli® received an indication expansion from the US FDA as combination therapy with carboplatin and paclitaxel for treating primary advanced or recurrent endometrial cancer. 

On 16 December 2024, Johnson & Johnson (J&J) announced that the US FDA issued a Complete Response Letter (CRL) for its US Biologics License Application (BLA) for a fixed subcutaneous combination of Rybrevant® (amivantamab-vmjw) and recombinant human hyaluronidase for non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. 

The CRL resulted from FDA inspection findings at a third-party manufacturing facility.  A representative for J&J stated that the company is “… working closely with the FDA to bring SC amivantamab to patients as quickly as possible, and are confident in [its] path to resolution”.  

In September this year, J&J received FDA approval for Rybrevant® in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).  

In November 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Rybrevant in combination with lazertinib, for first-line treatment of adult patients with advanced NSCLC.  Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will also consider this same indication at its March 2025 meeting for listing on the Pharmaceutical Benefits Scheme.