While Regeneron may have lost its latest bid to block the launch of Amgen’s Eylea biosimilar Pavblu, the New York-based pharma isn’t throwing in the towel just yet.
At the same time, Amgen appears to be moving full speed ahead on its rollout, which could prove to be the biggest U.S. loss of exclusivity in the pharma industry this year.
A trio of U.S. Circuit Judges on Tuesday denied Regeneron’s request for an injunction to block Amgen’s Eylea biosimilar launch as the company appeals a related decision issued last month.
“Without prejudicing the ultimate disposition of the issues on appeal, we conclude that Regeneron has not established that an injunction pending appeal is warranted,” the judges wrote in a court order filed this week.
The court did, however, grant Regeneron’s request to expedite the appeal process. Now, Amgen will need to submit its brief on the matter no later than Nov. 4 and Regeneron by Nov. 13 ahead of expected oral arguments scheduled for January.
With the latest decision, Amgen is eager to hit the market, with a spokesperson telling Fierce Pharma in no uncertain terms that “we are launching Pavblu.”
“We look forward to bringing Pavblu to patients as quickly as possible to help expand access to affordable and effective treatment,” Amgen's spokesperson added.
Regeneron, for its part, told Fierce Pharma that it continues to believe Amgen is infringing on its patent rights, stressing that the latest ruling “is not the final word in this litigation.”
“We have appealed the district court’s decision denying our request for a preliminary injunction, and we also look forward to presenting our case at trial,” a company spokesperson said over email.
Given that Regeneron has pledged to continue to fight in the case, Amgen appears to be content to launch Pavblu “at risk." Essentially, the company now has the ability to roll out its Eylea copycat onto the market. But the decision opens Amgen up to potential damages should Regeneron ultimately establish that patent infringement did occur.
The latest decision over Amgen’s Pavblu comes after U.S. District Judge Thomas Kleeh last month denied Renegeron’s request for a preliminary injunction as its patent case plays out.
Kleeh’s call came about a month after Amgen snagged an FDA approval for Pavblu, which references the original 2 mg version of Regeneron’s Eylea. Regeneron’s original complaint against Amgen listed 32 patents it alleged were infringed upon by Pavblu. Regeneron immediately appealed after last month’s legal loss.
Despite the recent decisions favoring Amgen, Regeneron has prevailed in several other attempts to block Eylea copycats.
In June, Judge Kleeh granted Regeneron’s requests for preliminary injunctions to block the sale of Biogen and Samsung Bioepis’ Eylea biosim Opuviz and Biocon’s copycat Yesafili until 2027. In that decision, Kleeh ruled that the biosimilars had in fact violated Regeneron patents.
Regeneron has also filed lawsuits against Eylea biosim hopefuls from Sandoz, Celltrion and Formycon.
Eylea, first approved in 2011, inhibits the growth of abnormal blood vessels in the retina and reduces fluid leakage. Following its initial green light in wet age-related macular degeneration, Eylea has also picked up nods in diabetic macular edema, retinal vein occlusion, diabetic retinopathy and retinopathy of prematurity.
Notably, Amgen got its copycat approved with a “skinny label,” which allows drugmakers to carve out certain indications held by the reference drug. Amgen’s Pavblu omits Eylea’s retinopathy of prematurity indication.
Eylea generated $5.72 billion in total U.S. sales last year, which represented 44% of Regeneron’s overall revenue of $13.12 billion.
While the launch of Amgen’s Eylea biosimilar would be a blow to Regeneron, the decision wouldn’t affect the company’s high-dose version of Eylea. The newer, longer-lasting drug is insulated from potential pricing impacts given that Amgen’s Pavblu would be the only off-brand Eylea available on the market, according to a September note from Evercore ISI analyst Cory Kasimov.