1. Alvotech launches Gobivaz, the first biosimilar to Simponi globally. 2. Introduction supported by NHS England tender, enhancing access to treatment. 3. Gobivaz will be available across EEA with national pricing processes. 4. CEO emphasizes importance for patients and high-quality treatment options. 5. Alvotech has five other approved biosimilars in multiple markets.
FAQ
Why Bullish?
The successful launch of Gobivaz under NHS tender indicates strong market potential, reminiscent of prior successful biosimilar launches which boosted stock prices, like Amgen's Enbrel biosimilar.
How important is it?
The introduction of a new product backed by NHS support directly influences revenue potential and market expansion prospects for ALVO.
Why Long Term?
Strategic market entries often yield sustained growth; historical data shows positive impact over multiple quarters. Alvotech's established partnerships and product approvals suggest a robust pipeline for future revenue.
Alvotech Launches Gobivaz®: A Milestone for Biosimilars in Europe
REYKJAVIK, ICELAND (December 22, 2025) — Alvotech (NASDAQ: ALVO), a leading global biotechnology company specializing in the development and manufacturing of biosimilars, has announced the European launch of Gobivaz® (golimumab), the world's first marketed biosimilar to Simponi® (golimumab), known as AVT05. This significant step in the biosimilars market is made possible through Alvotech's partnership with Advanz Pharma Holdco Limited, which will exclusively commercialize Gobivaz across Europe.
Support from NHS England Tender
The introduction of Gobivaz in the United Kingdom is reinforced by a favorable tender award from NHS England. This procurement decision establishes a structured framework for the integration of Gobivaz into NHS services, reflecting a broader commitment to enhancing patient access to high-quality biologic treatments for immune-mediated inflammatory diseases.
The rollout of Gobivaz in other European Economic Area (EEA) markets will depend on national pricing and reimbursement protocols, ensuring that the launch is aligned with local healthcare regulations.
Statements from Leadership
“We welcome the introduction of Gobivaz into clinical practice across Europe following its approval as the first biosimilar to Simponi worldwide,” stated Robert Wessman, Chairman and CEO of Alvotech. “Our biosimilar represents an important treatment option for patients, and the NHS England tender supports our aim of expanding the availability of high-quality biologic medicines.”
Approval and Manufacturing Details
The approval of Gobivaz was bolstered by extensive analytical, pre-clinical, and clinical studies demonstrating its biosimilarity to the reference product. Gobivaz is offered in the same dosage forms as Simponi and is produced at Alvotech's advanced manufacturing facility in Iceland.
About Alvotech
Founded by Robert Wessman, Alvotech is dedicated to becoming a leading player in the biosimilars marketplace by developing cost-effective and high-quality biosimilar medicines. Currently, Alvotech has five biosimilars approved and marketed globally, including treatments for conditions such as autoimmune diseases and cancer. The company is actively expanding its pipeline, which includes nine additional biosimilar candidates.
- Biosimilars currently marketed by Alvotech include:
- Humira® (adalimumab)
- Stelara® (ustekinumab)
- Simponi® (golimumab)
- Eylea® (aflibercept)
- Prolia®/Xgeva® (denosumab)
Alvotech’s strategic partnerships span various regions, including the United States, Europe, Japan, China, and parts of South America, Africa, and the Middle East, facilitating its global outreach.
Forward-Looking Statements
Certain statements in this release may include forward-looking statements, as recognized by the Private Securities Litigation Reform Act of 1995. These projections regarding Alvotech’s competitive advantages, product development pipeline, and regulatory approvals are subject to risks and uncertainties that could lead to actual results differing significantly from stated expectations. Investors are advised to consider risk factors outlined in Alvotech's SEC filings.