Regeneron Faces Setback as Court Upholds Ruling in Amgen Biosimilar Case

In a significant development for the pharmaceutical industry, Regeneron Pharmaceuticals has encountered a legal setback in its ongoing patent dispute with Amgen over the latter's biosimilar to Regeneron's blockbuster eye treatment, Eylea.

Appeals Court Affirms Lower Court Decision

The United States Court of Appeals for the Federal Circuit has upheld a lower court's ruling, finding that Regeneron failed to establish that Amgen's biosimilar, Pavblu, infringes on key Eylea patents. Judge Alan David Lourie, writing for the court, noted that "There is at least a substantial question of noninfringement," citing a distinct difference in Pavblu's formulation compared to Eylea.

This decision follows Regeneron's January 2024 lawsuit, which claimed that Amgen's development and marketing of Pavblu violated more than 30 Eylea patents. Regeneron had sought a permanent injunction against Amgen to prevent the commercialization of any product infringing on these patents.

Implications for Regeneron and Eylea Franchise

The court's decision adds to the challenges facing Regeneron's Eylea franchise. Recent financial reports indicate a decline in Eylea sales, with a 11% year-on-year drop in the fourth quarter of 2024. This decline is attributed to disappointing sales and increasing competition from other biosimilars.

In response to these challenges, Regeneron has been developing a high-dose formulation of Eylea. However, the rollout of this new formulation has faced difficulties, with fourth-quarter 2024 sales of $305 million falling short of analyst expectations of $336 million.

Looking Ahead: Regeneron's Future Prospects

Despite these setbacks, industry analysts remain cautiously optimistic about Regeneron's outlook. BMO Capital Markets analysts point to a "catalyst-filled 2025" for the company, highlighting several key developments:

1. The planned launch of prefilled syringes for high-dose Eylea by mid-2025.
2. Upcoming readouts for the biologic itepekimab in chronic obstructive pulmonary disease (COPD).
3. Results from trials of the LAG-3 therapy fianlimab in non-small cell lung cancer and melanoma.

Additionally, Regeneron recently received approval for its Sanofi-partnered drug Dupixent in COPD, marking it as the first biologic treatment approved for this indication. This development is expected to contribute positively to Regeneron's business moving forward.

As the pharmaceutical landscape continues to evolve, the outcome of this patent dispute and Regeneron's ability to navigate the challenges facing its Eylea franchise will likely have significant implications for both the company and the broader industry.