Sandoz prepares to toss Eylea competitor into the ring following positive PhIII readout

Regeneron may soon be staring down another competitor to its blockbuster Eylea. Sandoz’s biosimilar candidate aflibercept proved equivalent to the brand-name eye drug in a Phase III trial, Sandoz announced Tuesday.

The study pitted the biosimilar against Eylea in patients with neovascular age-related macular degeneration, an eye condition that can lead to vision loss. According to Sandoz, the biosimilar showed “therapeutic equivalence” to Eylea in mean change of best corrected visual acuity over eight weeks, and across safety, immunogenicity and pharmacokinetics. The results will allow the Novartis generics unit to file for approval in the US and EU “in the coming months.”

Eylea was first approved in 2011 for wet age-related macular degeneration and has since added a list of retinal conditions to its label, including macular edema secondary to retinal vein occlusion, diabetic retinopathy and others. The drug raked in more than $9.6 billion in worldwide sales in 2022, representing more than half the company’s total revenues. Multiple biosimilar competitors are vying for a chunk of that market, including Celltrion and Alvotech.

Eylea has regulatory exclusivity through mid-May 2024, thanks to a pediatric exclusivity designation in October 2022. However, the company holds other patents around methods of treatment that extend to 2032, according to Regeneron’s 2022 financial report.

Leonard Schleifer

Meanwhile, Regeneron is pushing for approval of its higher-dose version, which suffered a rejection in June. Regeneron blamed issues at a Catalent manufacturing site, and CEO Leonard Schleifer said on the company’s earnings call this month that there was “a clear understanding of the remediation work that’s required to allow the FDA to resume approving BLAs that involve manufacturing on this line.”

The news comes as Sandoz prepares to spin off from Novartis, which is expected to occur in the fourth quarter of this year, Novartis said in its most recent earnings report. The unit in June released a global action plan to boost biosimilar adoption by 2030, with the goal of improving biosimilar adoption by at least 30 percentage points in 30 target countries by the end of the decade.

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