Amgen is set to launch its biosimilar version of Regeneron's Eylea, known as Pavblu, after receiving a favorable ruling from the U.S. Court of Appeals for the Federal Circuit.
The court lifted a temporary injunction that had previously prevented Amgen from introducing the drug, rejecting Regeneron's claims that a market ban was necessary during the ongoing litigation.
This decision allows Amgen to enter a competitive market that has been dominated by Eylea, a drug that generated $1.53 billion in sales for Regeneron in the second quarter alone.
Despite the court's ruling, Regeneron plans to continue defending its patent rights and expressed disappointment over the decision.
The company intends to pursue legal action against Amgen and is moving patients to a newer, high-dose version of Eylea.
Amgen's decision to launch Pavblu at this time has surprised analysts, as it involves significant risk.
By entering the market now, Amgen could face substantial damages if the courts ultimately rule in favor of Regeneron regarding patent infringement.
The competitive landscape for Eylea is becoming crowded, with multiple biosimilars receiving FDA approval.
This influx of competitors poses a threat to Regeneron's Eylea franchise and could lead to price competition.
The appeals court's decision to lift the injunction was based on factors such as the likelihood of success on appeal and the potential for irreparable harm to Regeneron.
As Amgen prepares to launch Pavblu, the company faces the challenge of navigating the legal landscape while competing in a rapidly evolving market.
The outcome of the ongoing litigation will be closely watched by investors and industry stakeholders, as it will set important precedents for future biosimilar launches and patent disputes in the industry.