Dive Brief:

• Amgen is taking the risky step of preparing to launch a biosimilar version of Regeneron’s blockbuster Eylea drug after winning a victory in an ongoing legal battle.
• The U.S. Court of Appeals for the Federal Circuit on Tuesday lifted a temporary injunction that barred Amgen from introducing the medicine, rejecting Regeneron’s argument that the market ban was necessary as litigation progressed. The court did, however, grant Regeneron’s request to speed up legal proceedings, setting oral arguments for January.
• After the decision, Amgen said it’s planning to launch its Pavblu biosimilar “as quickly as possible.” Regeneron, meanwhile, expressed its disappointment in the ruling and said it will keep fighting. “We continue to believe that Amgen is infringing our patent rights,” Regeneron said. The appeals court decision on the injunction “is not the final word in this litigation,” it added.

Dive Insight:

Amgen’s decision to enter the market now surprised analysts. It means that the company is launching “at risk” and would be on the hook to pay Regeneron extensive damages if the courts ultimately find patent infringement. Amgen “has nerves of steel,” Piper Sandler analyst Christopher Raymond wrote in a note to clients.

Raymond said he had expected the California biotech to wait until after the appeals court arguments in January to launch Pavblu, given the risk of damages. Baird analyst Brian Skorney also expressed surprise at the move, but told clients in a note the threat of the launch might be a tactic to force a settlement, “which may be the best thing for both companies at this point.”

The latest legal skirmish began on Sept. 23, when a district court denied Regeneron’s motion for a preliminary injunction to prevent Pavblu from reaching the market. Two days later, the appeals court issued a temporary order to stop the launch while it reviewed briefs from the companies.

On Tuesday, the appeals court lifted that temporary injunction, saying Regeneron “has not established that an injunction pending appeal is warranted.” The court said it considered four factors: the likely success of the appeal, whether Regeneron would suffer “irreparable injury,” whether other parties would suffer substantial injuries and the public interest.

Regeneron is pulling out all the stops to protect its Eylea franchise, which brought in sales of $1.53 billion in the second quarter. Amgen isn’t the only threat to Eylea; two biosimilars from Biocon Biologics and Biogen won approval from the Food and Drug Administration in May. Sandoz and Formycon also secured clearances in June and August, respectively.

Among other steps, Regeneron is trying to move patients to a newer, high-dose version of Eylea. Eylea HD sales accounted for about $300 million of the franchise total in the second quarter.