On October 22, the federal appeals court denied Regeneron’s request for an injunction against Amgen pending appeal, which would have forestalled the biosimilar maker’s launch of Pavblu®, its biosimilar version of Eylea® (aflibercept). In late September, a judge from the District Court for the Northern Virginia District of West Virginia refused Regeneron’s original request for an injunction.
Regeneron has been embroiled in patent litigation against multiple prospective aflibercept biosimilar makers, in the hope of delaying competition for its reference drug Eylea. Although the other manufacturers have not reached a settlement or obtained relief in federal court, the path now seems clearer for Amgen to enter this $6 billion US market. Under the decision, oral arguments in the case will begin July 2025. Amgen must file its brief by November 4, and Regeneron’s response must be submitted by November 13.
As reported by Big Molecule Watch, a permanent injunction against launching its aflibercept biosimilar is in effect against Biocon Biologics, and preliminary injunctions are in effect against Celltrion, Formycon, and Samsung Bioepis, all but Celltrion having received FDA approval on their Eylea biosimilars.
According to unconfirmed reports, Amgen has launched the product “at risk” on October 30th, at a WAC price of $1,665. or about a 15% WAC discount from Regeneron’s reference product pricing. This court decision may convince Regeneron to settle with the other Eylea competitors. If that occurs, we would expect another wave of sequential launches in later 2025. As Eylea is generally a buy-and-bill drug covered under the medical benefit, the reference manufacturer may have less ability to hold on to market share in the face of heavy competition (similar to the experience of the oncology reference biologics). Lucentis® (ranibizumab), a principal competitor to Eylea, has only two biosimilar competitors, and has dropped to a 44% market share two years after biosimilar launches.
[This article was updated on October 30, 2024].
