UK High Court Clears Path for Alvotech’s AVT06 Biosimilar: European Market Entry Secured After SPC Expiry

Legal Victory Enables Manufacturing and Market Launch Post-SPC Expiry

Alvotech (NASDAQ: ALVO) secured a pivotal legal win this week as the UK High Court rejected an injunction sought by Regeneron and Bayer. The court’s decision means Alvotech and its UK-based contract manufacturer can proceed with production and stockpiling of AVT06—its biosimilar to Eylea (aflibercept)—setting the stage for broad European and UK market entry once the Supplementary Protection Certificates (SPC) for Eylea expire on November 23, 2025.

SPC Waiver Supports Competitive Biosimilar Launches Across Europe

The heart of this legal case centered on Europe’s SPC waiver framework, which exempts biosimilar manufacturers from certain patent infringement claims when preparing for commercial launches. By leveraging this waiver, Alvotech can now manufacture and stockpile AVT06 up to six months ahead of the SPC expiry. This supports swift and robust launches in both the European Economic Area (EEA) and the UK, and allows for export to other global markets during the SPC period.

Market Access Accelerates Following Recent Regulatory Approvals

With regulatory approvals already secured from the European Commission (August 21, 2025) and UK MHRA (August 28, 2025), Alvotech is poised for immediate entry into key markets upon SPC expiration. The AVT06 biosimilar is also approved in Japan, and its dossier is under review in additional major markets including the United States.

Strategic Implications: Market Access and Industry Impact

Chairman and CEO Robert Wessman emphasized that the ruling represents not only a legal win for Alvotech but also a boost for European biosimilars, aiming to bring manufacturing jobs and affordable biologics back to Europe. By maintaining uninterrupted manufacturing and stockpiling, Alvotech positions itself for strong commercial launches, giving patients faster access to essential therapies and enhancing competition against higher-priced branded drugs.

Biosimilar Pipeline Strengthens Alvotech’s Position

AVT06 targets the $8 billion global market for Eylea (aflibercept), a treatment for neovascular eye diseases. Alvotech’s expanding pipeline already includes two approved biosimilars (to Humira and Stelara), with nine more disclosed candidates covering key disease areas such as autoimmune and respiratory diseases, osteoporosis, and cancer. Global commercial partnerships—ranging from Teva and STADA to Fuji Pharma—underscore the company’s ambition for international reach and competitive positioning.

Takeaway: Legal Clarity Provides Tailwind for European Biosimilar Growth

The UK High Court’s clear affirmation of the SPC waiver’s functionality paves the way for efficient European market entry, reinforcing the importance of timely legal clarity in the evolving biosimilar landscape. Investors and industry observers will be watching Alvotech closely as it readies for its 2025 launches, particularly given the high value and widespread need for more accessible biologics in ophthalmology and beyond.

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