Regeneron Faces Setback as Court Upholds Ruling on Amgen's Eylea Biosimilar

In a significant development for the pharmaceutical industry, Regeneron Pharmaceuticals has encountered a major legal obstacle in its ongoing patent dispute with Amgen. The U.S. Court of Appeals for the Federal Circuit has affirmed a lower court's decision, dealing a blow to Regeneron's efforts to block Amgen's biosimilar version of its blockbuster eye medication, Eylea.

Legal Battle and Patent Infringement Claims

The appeals court, with Judge Alan David Lourie writing the opinion, upheld the ruling that Regeneron failed to adequately demonstrate that Amgen's biosimilar, Pavblu, infringes on Eylea's patents. This decision stems from a lawsuit filed by Regeneron in January 2024, alleging that Amgen's development and marketing of Pavblu violated more than 30 Eylea patents.

Judge Lourie noted, "There is at least a substantial question of noninfringement," highlighting a distinct difference in Pavblu's formulation compared to Eylea. The court concluded that "Regeneron has therefore not established a likelihood of success on the merits of its infringement allegations."

Market Implications and Financial Impact

The legal setback comes at a challenging time for Regeneron's Eylea franchise. The company's full-year business report revealed an 11% year-on-year decline in Eylea sales for the fourth quarter of 2024, reflecting a year of disappointing performance and increasing competition from other biosimilars.

Regeneron's high-dose formulation of Eylea, developed to bolster the franchise's revenues, has also faced difficulties. In Q4 2024, the high-dose injection generated $305 million in sales, falling short of analyst expectations of $336 million.

Future Outlook and Strategic Initiatives

Despite these challenges, industry analysts remain cautiously optimistic about Regeneron's prospects. BMO Capital Markets analysts have highlighted Regeneron's "catalyst-filled 2025," pointing to several key developments:

1. The planned mid-year launch of prefilled syringes for high-dose Eylea
2. Upcoming readouts for itepekimab in chronic obstructive pulmonary disease (COPD)
3. Clinical trial results for fianlimab in non-small cell lung cancer and melanoma

Additionally, Regeneron's partnership with Sanofi has yielded positive results, with their jointly developed drug Dupixent recently receiving approval for COPD treatment. This breakthrough makes Dupixent the first biologic therapy approved for this indication, potentially offsetting some of the challenges faced by the Eylea franchise.