Outlook Therapeutics are seeking to enter into a licensing and/or co-development rights agreement for ONS-5010 in Europe and UK .
Outlook Therapeutics voluntarily withdraws BLA after conversations with the FDA. The company expects to resubmit the BLA with additional supplemental information by September 2022 .
Outlook therapeutics announces it has submitted its its Biologics License Application (BLA) to the FDA for ONS-5010 for the treatment of wet AMD .
If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialise it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan and other markets .
Update from Outlook Therapeutics confirms that, with the registration clinical trials now completed, they intend to submit a BLA to the FDA Q1 2022 with approval anticipated Q1 2023. The company is also developing registration documents on a parallel path for approvals in Europe and expects to submit them shortly after completing the FDA submission. If approved, trials are also planned to investigate use of ONS-5010 in branch retinal vein occlusion and diabetic macular oedema. Outlook also plan to file a supplementary application for approval of the product in a pre-filled, silicone-free syringe, with a trial (NORSE SEVEN) planned to compare the safety of ONS-5010 in vials vs syringes .
Topline readout of data from PIII NORSE-2 study targeted for calendar Q3 21, and company plans to file a new Biologics License Application (BLA) filing to the FDA Q1 22. Registration documents are also being completed in parallel for approvals in Europe to be submitted shortly after completing the US filing. While Outlook Therapeutics continues to target potential strategic commercialisation partners, particularly for European markets, it is preparing to launch ONS-5010 in the United States by itself, pending FDA approval .
Outlook Therapeutics announces intention to submit MAA to European Medicines Agency for Retinal disorders in 2021 and commercial launch in 2022 .
Outlook is in active late-stage discussions for the licensing and/or co-development rights to ONS-5010, but could potentially market it. In the US it believes that ONS-5010 will be entitled to 12 years regulatory exclusivity against biosimilar competition. Despite widespread acceptance and use of bevacizumab to treat ophthalmic diseases such as wet AMD, DME and BRVO, no manufacturer has previously sought approval from FDA or EMA. Products provided off-label by compounding pharmacies can carry known risks of contamination (including silicone oil droplet contamination from syringes) and inconsistent potency, with potentially severe consequences, as leading retinal societies have reported. If ONS-5010 is approved and commercialised, Outlook expects it will be priced responsibly compared to other branded anti-VEGF therapies to help mitigate the high cost of treatment for retinal diseases .
Based on end-of-Phase 2 discussions with the FDA, Outlook believes that the results from NORSE 1 and NORSE 2, combined with our upcoming NORSE 3 safety study that is designed to ensure an adequate number of patient exposures to ONS-501, will be sufficient to support a new BLA submission in H2 2021 .
Outlook Therapeutics intends to complete development of ONS-5010 for submission to the FDA as a new BLA under the 351(a) PHSA regulatory pathway for the treatment of wet AMD and also has plans to submit for regulatory approvals in Europe, the UK and Japan, as well as other countries .
Company is also planning to file in the US for wAMD and other retinal diseases in 2021 .
Outlook currently intends to commercialize ONS-5010 in both vials and single-use pre-filled syringes .
Outlook therapeutics plan to submit ONS-5010 for regulatory approval in multiple markets in 2020 .
the company plan to submit ONS-5010 for regulatory approval in multiple markets in 2020 .
Oncobiologics is developing ONS-5010 as an innovative therapy and not using the biosimilar drug development pathway .