Australian based biosimilar manufacturer NeuClone has started phase 1 trials of its version of ustekinumab and has plans to launch other biosimilars for arthritic 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 psoriatic arthritis, Crohn’s disease and ulcerative colitis.
“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 rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and denosumab (Prolia) for osteoporosis. Other biosimilar candidates include versions of trastuzumab (Herceptin) and pertuzumab (Perjeta) for breast cancer.
The government is encouraging rheumatologists to use biosimilar brands rather than reference brands for agents such as etanercept and infliximab in arthritic conditions 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.