Oncobiologics announced first CTA approvals for global Phase 3 clinical program for ONS-3010

June 27, 2016 10:45 AM

Oncobiologics, Inc., a clinical-stage biopharmaceutical company, announced that its Phase 3 clinical plan for ONS-3010 (Humira biosimilar) has received the first of its European Union (EU) clinical trial authorization (CTA) approvals.

These approvals include in the United Kingdom, Germany and Spain, for the biosimilarity study portion of the Phase 3 clinical program of ONS-3010.

The global Phase 3 clinical program for ONS-3010 is expected to include recruitment and treatment of patients in approximately 20 countries, including the United States and various member states of the EU. The program study design is based on input from multiple Health Authorities including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and will include testing intended to enable interchangeability for Humira in the United States. The Phase 3 program will be conducted in patients with moderate to severe plaque psoriasis and is anticipated to begin dosing patients later in 2016.

“We are excited to move to this final clinical confirmatory stage to demonstrate that ONS-3010 is biosimilar to Humira,” said Kenneth Bahrt, M.D., Chief Medical Officer of Oncobiologics. “This study marks the beginning of our first Phase 3 program and is supported by positive data from our previous Phase 1 study of ONS-3010.”

Oncobiologics Chairman and Chief Executive Officer Pankaj Mohan, Ph.D., added, “These CTA approvals are another important step for Oncobiologics as we move to this final clinical confirmatory stage to demonstrate that ONS-3010 is biosimilar to Humira. It also highlights the unique capabilities of our fully integrated BioSymphony Platform as an in-house engine to develop and manufacture complex mAb biosimilars. In addition, we believe our proprietary formulation, for which we have filed a patent application, is an important differentiator for ONS-3010 that may provide improved tolerability compared to the originator product as reported in our successful Phase 1 trial. Ultimately, our goal is to offer a biosimilar product that provides both economic and therapeutic benefit to payors, buying groups, physicians and, most importantly, patients.”

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