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news.Clinical-stage biopharmaceutical Oncobiologics has announced the first of its European Union (EU) clinical trial authorization (CTA) approvals for global phase 3 program for ONS-3010, biosimilar to Humira.
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The approval, including in the UK, Germany and Spain, is for the biosimilarity study part of the phase 3 program, which is designed to allow interchangeability with Humira in US.
Under the phase 3 program, the company expects to recruit and treat patients in about 20 countries, including the US and several member states of the EU.
The program study design is based on input from multiple Health Authorities including the US Food and Drug Administration and European Medicines Agency .
It will include testing aimed at allowing enable interchangeability for Humira in the US.
The phase 3 program will be undertaken in patients with moderate to severe plaque psoriasis. Patient dosing is anticipated to start later this year.
Oncobiologics chairman and CEO Pankaj Mohan said: "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."