Clinical Trial Outcomes and Delays: The success and timing of clinical trials are critical for biosimilar approval and commercialization, and failure or significant delays could negatively impact Alvotech's prospects.

Regulatory Approval Uncertainty: Alvotech faces risks in obtaining timely and favorable regulatory approvals from health authorities like the FDA and EMA for its biosimilar candidates, which are essential for market access.

Intense Market Competition: The biosimilar market is highly competitive, with numerous players and originator companies, potentially impacting Alvotech's market share, pricing power, and profitability.