Demonstrated biosimilarity across clinical parameters puts this drug among NeuClone's leading product candidates.
NeuClone’s ustekinumab biosimilar candidate has met end points for similarity to the reference product (Stelara) in a phase 1 clinical trial, according to a company statement.
The reference version of ustekinumab is indicated for treatment of patients with plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.
The Sydney, Australia-based biosimilar company said its ustekinumab candidate (NeuLara) demonstrated clinical pharmacokinetic similarity to US- and EU-sourced Stelara samples. Safety, immunogenicity, and tolerability profiles of NeuLara also matched the reference product, NeuClone said.
“With successful completion of the phase 1 trial for NeuLara, our ustekinumab biosimilar is now significantly de-risked along its development path to market,” said Noelle Sunstrom, CEO of NeuClone.
“We are on track for a global phase III trial starting in 2021 and to be among the first biosimilar entrants, making this valuable antibody drug available to many more patients with psoriasis and inflammatory bowel diseases,” she said.
There are no ustekinumab biosimilars currently approved or marketed in either the United States or Europe.
Ustekinumab works by interfering with the cytokine signaling process that influences levels of inflammation in the body. In this way, ustekinumab suppresses the immune response and alleviates inflammatory disease.
The market for Stelara is estimated at $6.6 billion currently and the agent is among the top 10 drugs by sales, with projected 2024 revenues of $7.8 billion, NeuClone said, citing various sources.
For a recent interview with NeuClone's strategic analyst Thomas Wakim about the company's foray into biosimilars for PD-1 inhibitors, click here.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
June 16th 2024In this episode, The Center for Biosimilars® delves into the FDA approval of the first denosumab biosimilars, Wyost and Jubbonti (denosumab-bbdz), and discuss their potential to revolutionize osteoporosis treatment with expert insights from 2 rheumatologists.
Switching Patterns Highlight Nocebo Effect in European Patients Using Amgevita
July 23rd 2024About half of the patients in a European study who transitioned from reference adalimumab to a biosimilar version stayed on the biosimilar at the 1-year mark. However, researchers warned about a possible nocebo effect resulting in some patients switching back to the originator.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Eye on Pharma: EU Biosimilar Approval, Launches and Product Returns, Denosumab Switching Data
July 10th 2024The European Union approves a tocilizumab biosimilar and the US sees another launch, Genentech’s ophthalmology biobetter returns to the market, and Samsung Bioepis shares data on switching to its denosumab biosimilar.