Three months after a federal judge in West Virginia sided with Regeneron, blocking the market entry of two biosimilars for blockbuster eye disease drug Eylea, the same judge has rejected the company’s attempt to block Amgen’s Eylea biosimilar.
In an order issued under seal—which would explain his decision—Judge Thomas Kleeh of the U.S. District Court for Northern District of West Virginia denied Regeneron’s request for a preliminary injunction which would prevent Amgen’s Pavblu from entering the market.
The knockoff, which replicates the original 2 mg version of Bayer and Regeneron’s Eylea, was approved by the FDA last month. In its complaint against Amgen, which was filed in January of this year, Regeneron listed 32 patents it claimed were infringed. Upon the decision, the company immediately filed an appeal.
"We are disappointed in the court decision that was specific to Amgen only. Importantly, this decision has no effect on previous decisions against other biosimilars manufacturers of Eylea," Regeneron said in an emailed statement. "We continue to believe that Amgen is infringing our patent rights, and this decision denying our request for a preliminary injunction is not the final word in this litigation. We have appealed this decision, and we also look forward to presenting our case at trial."
The New York-based company’s regulatory exclusivity for Eylea—which was originally approved in 2011 to treat wet age-related macular degeneration (AMD)—expired in May, according to the complaint.
As Regeneron's case plays out, Amgen could now pursue an "at-risk" biosimilar launch. Under such an approach, the biosimilar maker would be liable for damages should Regeneron ultimately prevail in establishing patent infringement.
In the wake of the injunction decision, Regeneron’s shares dropped roughly 9% between Monday and Tuesday, an indicator of the company’s reliance on Eylea.
With U.S. sales of $5.9 billion in 2023, the vascular endothelial growth factor (VEGF) inhibitor accounted for 44% of Regeneron revenue of $13.1 billion.
An Amgen spokesperson said that the company will "announce our launch timing in due course,"
Eylea’s market share has been dented by Roche’s longer-acting Vabysmo, which requires dosing as little as every four months as opposed to every other month for Eylea. Regeneron has since countered with a high-dose (8 mg) version of Eylea. In the second quarter, Eylea HD accounted for $304 million of the $1.53 billion generated overall by the Eylea franchise.
The Amgen ruling runs counter to Kleeh’s decisions three days apart in June when he granted Regeneron’s requests for preliminary injunctions, blocking the sale of Biogen and Samsung Bioepis’ Eylea biosimilar Opuviz and Biocon’s Eylea copycat Yesafili until 2027. The court ruled that both knockoffs infringed Regeneron patents.
Opuviz and Yesafili were approved by the FDA in May as interchangeable biosimilars, meaning that a pharmacist can freely switch them out for the reference product.
Regeneron’s defense of Eylea is a high-priority endeavor for the drugmaker. Four weeks ago, the company filed a lawsuit in New Jersey against Sandoz and its Eylea biosimilar. The company also is jousting with South Korea-based Celltrion and Germany-based Formycon over their Eylea biosimilars.
Eylea works by inhibiting the growth of abnormal blood vessels in the retina and reducing fluid leakage. This mechanism helps in managing and treating conditions that lead to vision loss. In addition to its AMD nod, Eylea has been endorsed by the FDA to treat diabetic macular edema (DME), retinal vein occlusion (RVO), diabetic retinopathy (DR) and retinopathy of prematurity (ROP).