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.”
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