NeuClone Announces Positive Preclinical Results for Stelara® Biosimilar Candidate
核心洞察
NeuClone (搜索)'s biosimilar candidate for Stelara® (ustekinumab) shows comparable 3D structure to the reference product through X-ray crystallography.
The structural confirmation supports NeuClone (搜索)'s 'Right from the Start®' approach, ensuring high similarity to the original biologic from early development stages.
Clinical trials for the Stelara® biosimilar, developed in partnership with Serum Institute of India, are planned to begin in 2019.
NeuClone (搜索), a biopharmaceutical company, has announced positive preclinical results for its biosimilar candidate to Stelara® (ustekinumab), including 3-dimensional (3-D) structural confirmation via X-ray crystallography. The data confirm the identity and structural integrity of NeuClone's biosimilar, mirroring the reference product Stelara® in both primary amino acid sequence and 3-D folding.
Structural Similarity Confirmed
X-ray crystallography results demonstrated that NeuClone (搜索)'s biosimilar maintains the same structural integrity as Stelara®. This structural similarity is crucial for ensuring comparable efficacy and safety profiles, a key requirement for biosimilar approval.
Right from the Start® Approach
Dr. Noelle Sunstrom, CEO of NeuClone (搜索), stated, "These results validate our Right from the Start® approach to biosimilarity, demonstrating that NeuClone products are indistinguishable from their originator from the outset. Our ability to conduct crystallography, functional cell-based assays, and other Tier-1 biosimilarity tests in-house allows us to select the right candidate for clinical development."
Development and Clinical Plans
The Stelara® biosimilar is being developed in partnership with the Serum Institute of India. Production scale-up is underway, with Phase I clinical trials planned for 2019. This biosimilar is the company's second product to enter clinical trials in Australia, following their Herceptin® biosimilar.
The Importance of Analytical Data
Regulatory approval of biosimilars requires extensive analytical data to demonstrate structural and functional characterization comparable to the reference product. Techniques like X-ray crystallography are fundamental in establishing biosimilarity.
Market Context
Stelara®, marketed by Janssen (a Johnson & Johnson subsidiary), is a monoclonal antibody targeting both interleukin-12 (搜索) and interleukin-23 (搜索). It is currently approved for the treatment of several diseases, including plaque psoriasis (搜索) and Crohn's disease (搜索). In 2017, Stelara® achieved global sales of $4.0 billion, with projections estimating sales of $4.9 billion in 2022.