Regeneron Pharmaceuticals faced delays in two FDA decisions regarding the high-dose formulation of Eylea, as highlighted in the company’s Q2 report. The regulatory setbacks were attributed to manufacturing issues at Novo Nordisk-owned facilities. Originally scheduled for a decision on August 19, the FDA has now postponed its verdicts to the fourth quarter.
The affected supplemental applications for Eylea HD include its proposed use for treating macular edema after retinal vein occlusion and the expansion of dosing schedules to include a monthly regimen across approved indications. Notably, the delays do not stem from safety or efficacy concerns with Eylea HD but are linked to observations made at a Catalent manufacturing site, owned by Novo Nordisk. Despite Novo Nordisk’s responses to the FDA’s findings, the regulator deemed the submission as a major amendment, necessitating the extended review period.
Regeneron expressed confidence that once the manufacturing issues are resolved, the FDA will promptly process the applications. In the interim, Eylea HD vials will continue to be available in the U.S. for existing approved uses and dosing schedules. The disclosure of this delay was made during Regeneron’s second-quarter earnings report, where it was mentioned that the FDA required additional time for reviewing the Eylea HD applications due to unresolved manufacturing concerns at Novo Nordisk’s facility.
Although Regeneron anticipates a positive outcome upon resolution of the manufacturing issues, the delays pose a setback to the Eylea franchise. The once-dominant player in the retinal disease market has been facing market share challenges, particularly from competitors like Roche’s Vabysmo. Furthermore, Regeneron is bracing for the entry of biosimilars following the FDA’s approval of two interchangeable versions in May 2024. Biocon Biologics’ Yesafili is expected to enter the U.S. market late next year, while the timeline for the launch of the other biosimilar, Opuviz by Samsung Bioepis and Biogen, remains uncertain.
The revised timeline by the FDA for the Eylea HD decisions could potentially expedite the introduction of new Eylea versions, surpassing investor expectations. Analysts from BMO Capital Markets acknowledged the shorter regulatory path as a strategic move by Regeneron to counteract market erosion caused by biosimilar competition. Despite a 25% decline in year-on-year sales for the Eylea franchise in the second quarter, the revenue of $1.15 billion exceeded consensus forecasts by 9%.
Key Takeaways:
– Manufacturing issues at Novo Nordisk-owned facilities have led to FDA delays in decisions regarding Regeneron’s Eylea HD formulation.
– Regeneron’s Eylea franchise faces challenges from competitors and upcoming biosimilar entries following FDA approvals.
– The revised FDA timeline for Eylea HD decisions may offer Regeneron a quicker route to regulatory approval, aiding in market share retention and growth.
Tags: regulatory, formulation, biosimilars
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