Federal Circuit ruling allows Amgen’s Eylea biosimilar to stay on the market

Based on the search results, here are the key facts about the Federal Circuit ruling on Amgen's Eylea biosimilar:

The Federal Circuit affirmed a lower court decision that declined to temporarily block Amgen's biosimilar version of Regeneron's Eylea (aflibercept) from the market 14.
This ruling allows Amgen's biosimilar, called Pavblu (aflibercept-ayyh), to remain on the U.S. market 14.
Amgen had launched Pavblu in November 2024 after winning a previous court battle against Regeneron 13.
The Federal Circuit denied Regeneron's request for an injunction pending appeal in October 2024, which had allowed Amgen to proceed with launching Pavblu 12.
Pavblu was approved by the FDA in August 2024 12.
This biosimilar is entering a crowded market that includes Regeneron's original Eylea as well as a higher-dose formulation called Eylea HD 9.
The ruling centered around patent infringement claims by Regeneron related to its '865 patent 8.
The court found that Amgen's biosimilar formulation was different from Eylea's, as it did not contain a separate buffer component 8.
This decision contrasts with previous rulings that blocked other Eylea biosimilars from companies like Samsung Bioepis and Biocon from entering the market until 2027 4.
Amgen's successful defense and launch of Pavblu makes it the first Eylea biosimilar to reach the U.S. market 7.

In summary, the Federal Circuit's ruling keeps Amgen's Eylea biosimilar Pavblu on the market, marking a significant development in the competitive landscape for this important ophthalmic medication.