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Oncobiologics gets Dutch competent authority nod to begin Phase I trial for ONS-3010

PBR Staff Writer Published 13 June 2014

US-based Oncobiologics has received approval from the Dutch Competent Authority Centrale Commissie Mensgebonden Onderzoek (CCMO), to start 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 the company's Clinical Trial Application, CCMO 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 carried out by the Center for Human Disease Research in Leiden, The Netherlands.

The Phase I clinical trial is expected to be completed before the end of 2014.

Oncobiologics founder and CEO Pankaj Mohan said after the successful development campaign, the company is happy to see its 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," Mohan said.

Aldeyra CEO Todd Brady said as an advisor, he has witnessed the rapid development of Oncobiologics.

"Oncobiologics has built a team of respected industry leaders within the framework of an agile startup," Brady said.

"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."

Oncobiologics is focused on developing several additional biosimilars, including a biosimilar version of Avastin, which will be filed for its first clinical trial later in 2014.

The company is also pursuing biosimilar versions of Herceptin, Rituxan and Erbitux with plans to start studies in 2015 and thereafter.