Oncobiologics, Inc. announced today 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.
“After a very successful development campaign, we are excited to see our first biosimilar molecule enter this Phase I study. This represents the culmination of two years of hard work by our team, as well as proof-of-concept for our biosimilars business model, BioSymphony, which integrates our world-class CMC and manufacturing capabilities with the external clinical expertise of inVentiv Health, a top global CRO, and several regionally strong commercial partners around the world,” commented Oncobiologics Founder & CEO, Pankaj Mohan, Ph.D.
Aldeyra CEO Todd C. Brady M.D., Ph.D. added, “As an advisor, I have witnessed the rapid development of Oncobiologics and am thrilled to see the company take this exciting step. Oncobiologics has built a team of respected industry leaders within the framework of an agile startup. It is a testament to that team that Oncobiologics has been able to satisfy the challenging regulatory hurdles surrounding the development of complex mAb biosimilars. I look forward to the successful completion of this trial as well as the continued advancement of other potential products in the Oncobiologics pipeline.”
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.
