First Eylea biosimilars approved in US, but litigation blurs launch optics
Patent InfringementDrug Approval
Just days after a court in the US issued a temporary restraining order against biosimilar versions of Eylea (aflibercept), the FDA approved the first two products referencing Regeneron Pharmaceuticals’ eye disease drug. The agency also awarded the two biosimilars - Biocon’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy) - interchangeable status.
Regeneron warned earlier this year that biosimilar competition to Eylea might enter the market soon after the product’s exclusivity ran out on May 17. To combat this, the company has been pursuing legal action against a number of biosimilar developers, including seeking a permanent injunction against Viatris’ Mylan unit.
Late last year, Regeneron won a favourable judgement against Mylan in relation to a formulation patent that expires in 2027, while it is the early stage of litigation with at least four other drugmakers. According to Morgan Stanley analysts, Regeneron is hoping that a permanent injunction against Mylan would stop the launch of its biosimilar during the appeals process, while a preliminary injunction would provide certainty that the other companies could not enter the market during litigation in the district court, which they noted could take 2-3 years from the lawsuit filing date.
Decision expected soon on injunctions
Morgan Stanley analysts said that the temporary restraining order is effective for 14 days, starting from May 17, although it was only issued against Mylan and Samsung Bioepis. However, they surmised that the other companies pursuing Eylea biosimilars likely agreed not to launch until after a decision on the preliminary injunction motion is reached.
While it is unclear when the court will issue decisions on the injunctions, Morgan Stanley analysts suggested that as the temporary restraining order expires in two weeks, “we expect a decision soon,” led by a ruling on the permanent injunction.
According to the FDA, both Yesafili and Opuviz are indicated to treat neovascular age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema and diabetic retinopathy. The reference product generated sales in the US of $5.7 billion last year, but is coming under pressure from Roche’s Vabysmo (faricimab-svoa) and the looming threat of biosimilars. Regeneron has been trying to maintain market share with its high-dose version of Eylea, which has seen increased uptake.
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