Australian based biosimilar manufacturer NeuClone has started phase 1 trials of its version of ustekinumab and has plans to launch other biosimilars for gastroenterology-related conditions.
The Sydney-based manufacturer says it has commenced a dosing trial in Australian centres of a ustekinumab biosimilar candidate, NeuLara, in over 200 healthy volunteers.
If approved by the TGA, the product could be a biosimilar alternative to the muti-billion dollar selling Stelara, the monoclonal antibody targeting interleukin-12 and -23, which is licensed for Crohn’s disease, ulcerative colitis and psoriatic arthritis.
“The primary objective is to demonstrate equivalent pharmacokinetics (PK) and secondary objective is to demonstrate equivalent safety of NeuLara to US- and EU-sourced Stelara,” a company statement said.
NeuLara is the second biosimilar from NeuClone’s pipeline to enter clinical development and is developed in partnership with Serum Institute of India.
The company is reported to have six biosimilar products in its development pipeline including alternatives to adalimumab (Humira) for Crohn’s Disease. Other biosimilar products include denosumab (Prolia) for osteoporosis, and trastuzumab (Herceptin) and pertuzumab (Perjeta) for breast cancer.
The government is encouraging rheumatologists to use biosimilar brands rather than reference brands through its biosimilar uptake driver policy, which confers fewer PBS authority restrictions on biosimilar brands.
In May this year the Generic and Biosimilar Medicines Association (GBMA) launched a biosimilar education hub to provide information on biosimilars to prescribers, pharmacists, and patients.