The UK High Court’s decision on November 10 2025 to reject Regeneron and Bayer’s injunction removes a key legal obstacle that had delayed Alvotech’s ability to manufacture and stockpile its Eylea biosimilar, AVT06, in the United Kingdom. The ruling allows the company to proceed with commercial preparations once the originator’s Supplementary Protection Certificates expire on November 23 2025, positioning Alvotech to capture market share in a high‑value ophthalmology segment.
AVT06 received European Commission approval on August 21 2025 and UK MHRA approval on August 28 2025, but the SPC waiver was required to enable manufacturing in the UK. With the court’s decision, Alvotech can now store the product and begin distribution immediately after the SPC expiry, potentially generating revenue from a drug that previously commanded $9.5 billion in global sales in 2024.
The ruling strengthens Alvotech’s competitive stance against originator companies and other biosimilar developers such as Amgen, Sandoz, Pfizer, and Samsung Bioepis. By clearing the legal barrier, Alvotech can accelerate its launch timetable, reduce time‑to‑market, and begin capturing the anticipated share of the Eylea market that will open once the SPCs lapse. The company’s broader strategy of expanding its biosimilar portfolio in major markets is reinforced, and the decision signals that Alvotech can navigate complex patent and SPC landscapes successfully.
Robert Wessman, Alvotech’s Chairman and CEO, said the outcome was “never in doubt in my mind” and that the ruling “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.” He highlighted the importance of the SPC waiver system for European biosimilar manufacturers and the objective of bringing biosimilar production back to Europe.
Investors reacted positively to the ruling, noting that the decision removes a significant headwind and unlocks a revenue stream that will begin after the SPC expiry. The market view is that Alvotech’s ability to launch AVT06 in the UK will enhance its earnings profile and provide a foothold in a lucrative ophthalmology market.
The court’s decision is a milestone for Alvotech, confirming its capacity to overcome regulatory and legal challenges and positioning the company to capitalize on the upcoming opportunity in the Eylea biosimilar market.
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