Both Biocon and partners Samsung Bioepis/Biogen have reason to cheer today: The FDA approved their respective aflibercept biosimilars, Yesafili™ (aflibercept-yszy) and Opuviz™ (aflibercept-jbvf), for the following indications:
- Neovascular (wet) age-related macular degeneration
- Macular edema following retinal vein occlusion
- Diabetic macular edema
- Diabetic retinopathy
With its announcement, the regulator has further clouded the issue of interchangeability (if that was even possible). The FDA designated both agents as interchangeable, which doesn’t seem feasible under the existing policy, as only one agent is supposed to have an initial one-year exclusivity for the designation.
Further, these agents are not covered under the pharmacy benefit, and thus, cannot be automatically substituted for the reference product. It is possible in some instances that they are dispensed by a specialty pharmacy and sent directly to the physician’s office, which would provide an opportunity for autosubstitution. The FDA had provided the interchangeable designation to a biosimilar ranibizumab (Byooviz®), which is also primarily a medical benefit (buy-and-bill) product. Once again, the interchangeability designation has no bearing whatsoever on the clinical outcomes or quality of the product relative to a noninterchangeable biosimilar agent.
Amgen, Celltrion, and Formycon are all expecting FDA decisions on their own aflibercept biosimilars before the end of 2024. The actual launch date of any of these biosimilar agents is unclear. Regeneron’s exclusivity for reference product Eylea® expired on May 18, 2024, but patent litigation may delay the biosimilar launches.
In Other Biosimilar News
Xbrane Biopharma received a complete response letter from the FDA regarding its 351(k) application for Xlucane™. This was the second time Xbrane had gone through the process, after withdrawing its initial application in the second quarter of 2022. The FDA cited manufacturing site deficiencies as well as an issue with an analytical method used in characterizing the agent. In its press release, Xbrane expressed confidence in working through the issues with the FDA and is expected to announce a new application refiling date.
