Notably, Oncobiologics revealed that it is developing the bevacizumab product as an innovator therapy, and it will not use the biosimilar pathway for eventual approval.
Oncobioloigcs has announced that it has dosed the first patients with wet age-related macular degeneration (AMD) in a clinical trial of ONS-5010, an ophthalmic bevacizumab candidate.
The start of the trial follows what Oncobiolgoics termed a “successful” Phase 2 meeting with the FDA earlier in 2018, and a phase 1 clinical trial. In the phase 1 study, ONS-5010 met all of its pharmacokinetic endpoints and met bioequivalence criteria when compared with both US- and EU-sourced reference bevacizumab.
“The commencement of the ONS-5010 clinical program targeting ophthalmic indications is a major achievement and I am extremely proud of the team for reaching this key milestone so quickly,” said Lawrence A. Kenyon, president, CEO, and CFO of Oncobiologics, in a statement announcing the trial. “We were able to enter the clinic in less than 12 months from the start of the project. ONS-5010 presents an exciting opportunity to meet the need for affordable critical therapeutic options for patients and we are planning to build on the progress achieved to date.”
The ophthalmic formulation of bevacizumab will be administered as an intravitreal injection to treat wet AMD as well as other diseases of the retina, and Oncobiologics says that, if eventually approved, the drug will be available in a single-use vial for injection.
Notably, Oncobiologics revealed that it is developing the product as an innovator therapy, and it will not use the biosimilar pathway for eventual approval. While the innovator bevacizumab (Avastin) is frequently used to treat eye diseases, and while it has been demonstrated to be markedly more cost-effective than other anti—vascular endothelial growth factor therapies (such as aflibercept and ranibizumab) in this setting, neither the innovator drug nor its first approved biosimilar (Mvasi) have approved indications for intravitreal injections. The lack of regulatory approval to treat AMD and other eye disorders with bevacizumab has not stopped some health systems—such as the United Kingdom’s National Health Service (NHS)—from making extensive use of bevacizumab for eye diseases. In September, a UK court issued a ruling allowing the NHS to treat patients with AMD using bevacizumab without an EMA approval.
Oncobiologics’ choice to pursue a ONS-5010 as an innovator drug rather than a biosimilar is also because of the fact that the company also revealed that it has committed itself to selling or licensing the rights to some or all of its clinical-stage biosimilars as part of an effort to reduce its expenses. Oncobiologics’ current pipeline includes biosimilars of adalimumab, trastuzumab, denosumab, and ustekinumab, as well as another bevacizumab molecule, ONS-1045.