Date: 2016-11-14
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the 2016 American College of Rheumatology Annual Scientific Meeting
Company: Oncobiologics (USA - NJ)
Product: ONS-3010 (biosimilar version of Humira® (adalimumab))
Action
mechanism: biosimilar/monoclonal antibody/TNF alpha inhibitor
Disease:
Therapeutic
area: Autoimmune diseases
Country: The Netherlands
Trial
details:
Latest
news:
- • On November 14, 2016, Oncobiologics presented final data from the Phase 1 trial evaluating bioequivalence of ONS-3010 (Humira® biosimilar) and the US and European originator versions of Humira® (adalimumab). The data was presented at the 2016 American College of Rheumatology Annual Scientific Meeting in Washington, on November 13, 2016. The Phase I trial demonstrated pharmacokinetic bioequivalence on the primary and secondary endpoints for the biosimilar candidate and the US and EU originator product (Humira). There was no significant difference in immunogenicity or overall safety, except for a reduction in the burning sensation at the ONS-3010 injection site.
Three randomized, gender-balanced groups of 66 healthy subjects received single subcutaneous doses of 40mg of either ONS-3010 or Humira® (EU or US product). Blood samples were collected at regular intervals for PK and immunogenicity testing. Bioequivalence (BE) was assessed using general linear model procedures. Adverse events and serious adverse events were monitored and recorded.
Top line results included: The PK profiles for E.U. Humira®, U.S. Humira® and ONS-3010 were similar in outcome.
Adverse events were evenly divided over treatments, usually mild in severity, and self-limiting. A single serious adverse event (bacterial abscess) occurred in the ONS-3010 arm.
Immunogenicity results showed similar profiles in the three treatment groups for anti-drug and neutralizing antibodies.
- • On February 12, 2015, Oncobiologics announced that ONS-3010, its adalimumab (Humira®) biosimilar candidate met the primary endpoints in its first clinical study. A 3-arm single-dose pharmacokinetic (PK) study was performed in healthy volunteers to compare ONS-3010 to both the US- and EU-sourced Humira® reference products, and the two reference products to each other. All of the PK endpoints met the bioequivalency criteria of the geometric mean ratios within 90% confidence interval of 80-125%. These included: maximum serum concentration (Cmax), area under the time-concentration curve from first time point extrapolated to infinity (AUC0-inf), and area under the time-concentration curve from first to last time point measured (AUC0-t). Safety and immunogenicity were similar across the three arms. An exploratory ex vivo pharmacodynamic study also showed encouraging results between ONS-3010 and the reference products on TNF-? blockade and the induction of specific inflammatory responses. This first-in-human study was conducted by the Centre for Human Drug Research (CHDR) in Leiden, The Netherlands.
- • On June 12, 2014, Oncobiologics announced that it has received approval to initiate a Phase I clinical trial in Europe for its first biosimilar molecule, ONS-3010, a highly biosimilar version of the marketed drug, Humira®. After reviewing Oncobiologics\' Clinical Trial Application, the Centrale Commissie Mensgebonden Onderzoek (CCMO), the Dutch Competent Authority, has provided a Letter of No Objection, and the Independent Ethics Committee of the Foundation \"Evaluation of Ethics in Biomedical Research\" has approved a Phase I trial to be conducted by the Center for Human Disease Research in Leiden, The Netherlands. The study is expected to be completed before the end of 2014. Oncobiologics is developing several additional biosimilars, including a biosimilar version of Avastin®, which will be filed for its first clinical trial later in 2014. Oncobiologics is also pursuing biosimilar versions of Herceptin®, Rituxan® and Erbitux® with plans to initiate studies in 2015 and thereafter.
Is
general: Yes
