Cranbury, New Jersey-based Oncobiologics announced that its Phase 3 clinical strategy for ONS-3010 (Humira biosimilar) has been granted the first of its European Union (EU) clinical trial authorization (CTA) approvals, including Spain, Germany, and the United Kingdom, for the biosimilar trial portion of the Phase 3 clinical program, which targets moderate to severe plaque psoriasis.
ONS-3010 is being developed as a biosimilar to Humira (adalimumab), an anti-TNF-alpha monoclonal antibody, which is approved in many countries for the treatment of multiple inflammatory diseases that include rheumatoid arthritis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis, as well as several pediatric indications.
ONS-3010 has the same amino acid sequence, pharmaceutical dosage form, and strength, but contains a formulation of different composition.
The global ONS-3010 Phase 3 clinical program will recruit and treat patients with moderate to severe plaque psoriasis across nearly 20 countries. The clinical program protocol is based on involvement from multiple health authorities, including the European Medicines Agency (EMA) and the U.S. FDA, and will include testing intended to allow interchangeability for Humira in the U.S. Patient dosing is expected later this year.
“We are excited to move to this final clinical confirmatory stage to demonstrate that ONS-3010 is biosimilar to Humira,” Kenneth Bahrt, M.D., chief medical officer of Oncobiologics, said in a recent press release. “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.”
“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,” said Oncobiologics Chairman and CEO Pankaj Mohan, Ph.D. “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,” Mohan said.