Outlook Therapeutics’ hopes for a manufactured version of bevacizumab for ophthalmologic use have been significantly delayed. And its recent announcement that it is now targeting the end of 2024 for submitting its revised 351(a) application may push launch off until late 2025.
The problem stems from Outlook Therapeutics’ initial clinical trial results, described in the first biologic licensing application submission. The FDA cited “a clinical deficiency” in its complete response letter to the company last year. After consultations with the FDA, and receiving the green light for its next clinical study, Outlook dosed its first patient last week. This new phase 3 study is targeted for completion in October. Progress towards approval of ONS-5010 has been a long road indeed.
Outlook Therapeutics faces an uncertain future. ONS-5010 would be its first product approval, and the timing gets increasingly difficult, notwithstanding its financial picture.
The net price of ranibizumab (in many respects, a very similar agent to bevacizumab), which is used to treat the same macular degeneration disorders, are dropping after only a year of biosimilar competition. The average sales price is as low as $867 per 0.5-mg dose, a cut of 56% compared with the wholesale average cost of the reference product Lucentis® at the time of biosimilar launch. Another problem for Outlook is the potential launch of multiple aflibercept biosimilars later this year, assuming patent issues are resolved.
The company may be in a race against time, one that it is not winning.
Celltrion’s Tocilizumab Biosimilar
Celltrion USA announced that the FDA has accepted its 351(k) application for a new tocilizumab biosimilar. This represents the third Actemra® biosimilar filed for approval. Tocilizumab is an IL-6 receptor antagonist.
“The submission of CT-P47 for review is an important step toward providing patients with rheumatoid arthritis a more accessible avenue to treatment for conditions that present such a significant disease burden,” stated Thomas Nusbickel, Chief Commercial Officer at Celltrion USA in a press release.
Based on FDA’s timelines, a decision on CT-P47 can be expected from the agency in the late fourth quarter of this year or early first quarter of 2025. Partners Bio-Thera and Biogen received the first approval in the category September 29, 2023. It is not yet marketed.