ONS-3010 was developed as a biosimilar of adalimumab, which is an injectable, synthetic (man-made) anti-TNF-alpha monoclonal antibody that binds to TNF (tumor necrosis factor) and blocks inflammation. This drug has been approved in several countries for the treatment of inflammatory conditions, such as psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis and Crohn’s disease, among others. ONS-3010 from Oncobiologics has the same amino acid sequence as adalimumab, identical pharmaceutical dosage scheme and strength, though its formulation has a different composition.
In this first clinical trial, healthy volunteers were enrolled in a 3-arm single-dose pharmacokinetic (PK) study for a comparison between the ONS-3010 and the US- and EU-sourced Humira® reference products. The researchers concluded that all the PK endpoints fulfilled the bioequivalency criteria of the established geometric mean ratios, namely the area under the time-concentration curve from first time point extrapolated to infinity, area under the time-concentration curve from first to last time point measured, and maximum serum concentration.
In terms of immunogenicity and safety, all three compounds showed similar results. In addition, an exploratory ex vivo pharmacodynamic study performed at the Centre for Human Drug Research (CHDR) in Leiden, The Netherlands showed promising results for ONS-3010 in comparison with the two reference products regarding TNF-alpha blockade and the induction of particular inflammatory responses.
“The clinical PK similarity study is a required regulatory milestone for biosimilar development. We are excited to report that ONS-3010 has met the PK endpoints, which strengthens our confidence in achieving the global development of ONS-3010 as a biosimilar to Humira®,” said the Chief Medical Officer at Oncobiologics, Dr. Claude Nicaise in a news release.
Oncobiologics Founder & CEO, Dr. Pankaj Mohan added, “These clinical results are further validation of our unique BioSymphony platform. Our internal R&D, manufacturing, regulatory and clinical teams, and our strategic partners, CHDR and inVentiv Health, have worked exceptionally well together to achieve this important milestone. We look forward to executing the next clinical phase for ONS-3010, as well as the advancement of the remaining assets in our biosimilar pipeline.”