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.
Eye on Pharma: Bevacizumab Update; Samsung Bioepis, J&J Settlement; Another EU Trastuzumab
December 6th 2023Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.
Dr Fran Gregory Sizes Up the US Adalimumab Market: Will Biosimilars See Success?
September 17th 2023On this episode of Not So Different, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, analyzes the adalimumab market so far in the United States and provides insight into how the market needs to adapt to accept these products and ensure lower drug costs for patients.
Study Documents HCPs’ Experiences of a Mandatory Switch to Inform Future Transitions
December 2nd 2023A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.
How Streamlining Development Can Save the US Biosimilar Industry
August 20th 2023On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, expanded on ways to make biosimilar development faster and cheaper without compromising on safety and efficacy and how these practices can ensure a sustainable market for the future.
Phase 1 Study Finds Comparable PK, PD Parameters in Biosimilar GP40141 vs Reference Romiplostim
November 25th 2023A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.