Alvotech announced the start of commercial sales of Gobivaz® in the European Economic Area, the company’s first biosimilar to the reference biologic Simponi® (golimumab). The launch is being executed exclusively by partner Advanz Pharma Holdco Limited and is available in both pre‑filled syringe and autoinjector formats, positioning the product for rapid uptake by clinicians who prefer the convenience of single‑dose devices.
Gobivaz’s entry into the market is historic: it is the first Simponi® biosimilar to reach global availability. The launch is underpinned by a tender award from the National Health Service (NHS) England, which provides a clear reimbursement pathway and signals strong demand in the United Kingdom. The NHS award also gives Alvotech a foothold in a key payer market, creating a template for expansion into other European countries as national pricing and reimbursement processes progress.
The launch comes at a time when Alvotech is navigating significant financial and regulatory challenges. In Q3 2025 the company reported revenue of $114 million, slightly below the $115.2 million consensus estimate, and an earnings per share of $0.47 versus the expected –$0.03, a beat of $0.50. Total revenue for the first nine months of 2025 rose 24% year‑on‑year to $420 million, but adjusted EBITDA fell 21% to $68 million, reflecting higher R&D spend and lower licensing income. In response to a Complete Response Letter from the FDA for its Reykjavik‑manufactured golimumab biosimilar candidate, Alvotech cut its 2025 revenue guidance to $570‑$600 million and adjusted EBITDA guidance to $130‑$150 million, down from earlier forecasts of $570‑$600 million and $130‑$150 million, respectively, underscoring the impact of regulatory headwinds on the company’s financial outlook.
CEO Robert Wessman welcomed the Gobivaz launch, noting that the product “provides an important treatment option for patients with immune‑mediated inflammatory diseases and that the NHS England tender supports our goal of expanding access to high‑quality biologic medicines.” Wessman emphasized that the partnership with Advanz Pharma will accelerate market penetration and that the launch is a key milestone in Alvotech’s strategy to strengthen its biosimilar portfolio in high‑margin therapeutic areas.
Alvotech’s stock rose 3.59% on the day of the launch announcement, reflecting investor optimism about the first global entry of a Simponi® biosimilar. Analyst sentiment was mixed: while some analysts highlighted the launch as a positive tailwind, others, such as Barclays, issued an “Underweight” recommendation with a $5.00 price target, citing ongoing manufacturing deficiencies and the FDA CRL as significant risks that could temper future growth.
The Gobivaz launch represents a strategic win for Alvotech, but the company must still address the manufacturing and regulatory challenges that have weighed on its financial guidance. The NHS tender provides a strong reimbursement foundation, yet the company’s ability to scale production and secure approvals in other markets will determine whether the launch translates into sustained revenue growth. The partnership model with Advanz Pharma remains a core element of Alvotech’s commercialization strategy, offering a balance between rapid market entry and shared risk, while the company’s broader pipeline of biosimilar candidates continues to offer potential upside if regulatory hurdles are overcome.
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