Accord BioPharma received approval for Filkri, a filgrastim biosimilar, and Outlook Therapeutics journey to approval for its ONS-5010 continues after an FDA rejection.
A Filkri Approval for Accord BioPharma
In mid-February, Accord BioPharma announced that it had received FDA approval for Filkri (filgrastim-laha), making it the fifth filgrastim biosimilar to obtain approval (not counting Granix, a 505[b]2 product that launched before the biosimilar approval pathway was established). Accord now has both filgrastim and pegfilgrastim biosimilars in its portfolio. It had acquired the Udenyca franchise from Coherus in 2024.
Biosimilar uptake in the filgrastim category (reference product, Neupogen) is approximately 75%, according to the latest Samsung Bioepis Biosimilar Trend Report. The discount in average sales price (ASP) since the introduction of filgrastim biosimilars in 2015 has been 74%.
Outlook Therapeutics Rejected Again by FDA
The battle to bring a manufactured bevacizumab for ophthalmic use is not yet over in the US. Although approved by the European Medicines Agency, Outlook Therapeutics ONS-5010 has been in a long-term journey to US commercialization.
“The [latest complete response letter] identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence,” according to a press release from February 17. “Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the [biologic licensing application], including data from an adequate and well-controlled study and confirmatory evidence of effectiveness.” Outlook indicated that discussions with the FDA since September 2025 seemed to indicate alignment with the agency on the important issues. The company has sought additional meetings with the FDA to understand a path forward.
Indeed, we have been following Outlook Therapeutic’s journey for several years, along with its complete response letters in 2023 and 2024. With the low cost of compounded bevacizumab and its high utilization in retinal disease, it was hoped a manufactured version of this product for intravitreal injection would help address safety and purity concerns with compounding and at well below the cost of ranibizumab and aflibercept. However, with heavy biosimilar competition by later this year for the latter, it may be more difficult to leverage a much lower price point for ONS-5010 if launched in 2027.
This article was written by our Director of Content, Stanton Mehr. Stan is has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.
