The UK High Court on November 10 2025 rejected the injunction sought by Regeneron and Bayer against Alvotech, allowing the company to proceed with manufacturing and marketing its AVT06 biosimilar to Eylea. The decision removes a key legal barrier and sets the stage for a commercial launch after the expiry of Eylea’s Supplementary Protection Certificates on November 23 2025.
Regeneron and Bayer argued that Alvotech’s planned launch would infringe on patents and that the SPC waiver would be abused. The court found that the evidence did not establish a sufficient basis for an injunction and dismissed the expedited infringement proceedings that had been pending since earlier this year. The ruling confirms the validity of the UK’s SPC waiver regime, which permits biosimilar manufacturers to stockpile products before patent expiry to ensure timely market entry.
For Alvotech, the ruling unlocks a significant revenue opportunity. AVT06 is expected to launch in the UK shortly after the SPC expiry, with plans to expand into other European markets. The company’s CEO, Robert Wessman, said the decision “will allow Alvotech to proceed with its manufacturing activities and supports bringing our biosimilar to patients and caregivers in Europe and the rest of the world.” If AVT06 captures even a modest share of the Eylea market, it could generate hundreds of millions of dollars in annual sales and accelerate Alvotech’s growth trajectory.
Regeneron’s Eylea franchise has already shown signs of erosion. In Q1 2025, Eylea sales fell 26% to $1.04 billion compared with the same period in 2024, while Q3 2024 sales grew 3% to $1.54 billion. In 2024, U.S. revenue for Eylea 2 mg and Eylea HD totaled $5.97 billion, a 1% increase over 2023. The entry of AVT06 threatens to accelerate price pressure and further dilute Regeneron’s market share, prompting the company to focus on its higher‑dose Eylea HD and other product enhancements.
The ruling also signals a broader shift in the biosimilar landscape. In addition to Alvotech’s AVT06, other aflibercept biosimilars from Formycon, Sandoz, Samsung Bioepis/Biogen, Biocon, and Amgen have received or are seeking approval in Europe and the U.S., while Roche’s Vabysmo remains a strong competitor. The UK decision reinforces the enforceability of SPC waivers and may encourage other biosimilar developers to pursue similar strategies, potentially reshaping the competitive dynamics of the retinal disease treatment market.
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