Alvotech and Advanz Pharma Secure EMA's Green Light for Gobivaz® Biosimilar, Opening New Treatment Pathways in Europe

Alvotech (NASDAQ: ALVO) and Advanz Pharma have reached a critical regulatory milestone as the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for Gobivaz®, a biosimilar to Simponi® (golimumab). The positive opinion from EMA’s CHMP paves the way for broader patient access across European markets and represents a significant advancement in the biosimilar landscape.

Partnership Framework Drives European Expansion

The collaboration between Alvotech, a global biotech firm specializing in biosimilar development and manufacturing, and Advanz Pharma, a UK-based pharmaceutical company with focus on specialty and rare disease medicines, combines complementary strengths. Alvotech handles development and commercial supply of Gobivaz®, while Advanz Pharma leads registration efforts and holds exclusive commercialization rights throughout Europe. This partnership structure positions both companies to accelerate patient access to cost-effective treatment alternatives.

“We look forward to working with Advanz Pharma to increase access for patients and healthcare professionals to golimumab, as the reference biologic Simponi® remains an important treatment option for numerous immune-mediated diseases,” noted Joseph McClellan, Chief Scientific and Technical Officer for Alvotech. Nick Warwick, Chief Medical Officer at Advanz Pharma, added, “The positive CHMP opinion for Gobivaz® is an important milestone in expanding patient access and marks a significant step forward in Advanz Pharma’s ambition to build a leading biosimilars presence in Europe.”

Approved Formulations and Therapeutic Indications

The CHMP recommendation covers Gobivaz® in two formulations: 50 mg/0.5mL and 100mg/mL, both provided as pre-filled syringes and autoinjectors. The approved indications span rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis in adult patients, plus juvenile idiopathic arthritis. The authorization extends across the 27 European Union member states, along with Norway, Iceland, and Liechtenstein.

The underlying mechanism involves golimumab’s action as a monoclonal antibody targeting tumor necrosis factor alpha (TNF alpha), a key inflammatory mediator implicated in chronic autoimmune and inflammatory conditions. By inhibiting TNF alpha, Gobivaz® can help suppress the excessive immune responses characteristic of these diseases.

Clinical Evidence Supporting the Biosimilar

Alvotech’s development program included rigorous comparative studies. In November 2023, the company released positive results from a pharmacokinetic study assessing safety, tolerability, and pharmacokinetic parameters of AVT05 (Gobivaz’s development name) against Simponi® in healthy participants. These findings were followed by April 2024 data from a confirmatory clinical trial comparing efficacy, safety, and immunogenicity in patients with moderate to severe rheumatoid arthritis, demonstrating biosimilar comparability to the reference product.

What Lies Ahead

While the CHMP positive opinion represents a crucial endorsement, Gobivaz® remains pending final approval by the European Commission. The regulatory pathway continues toward commercial availability, contingent upon satisfactory completion of the final authorization stage. Pending European Commission decision, this biosimilar is poised to enter the market and provide healthcare systems and patients with a therapeutically equivalent, cost-efficient option to Simponi®.

Broader Implications for the Biosimilar Market

This approval recommendation underscores growing momentum in the European biosimilars sector. As TNF alpha inhibitors like golimumab remain cornerstone therapies for chronic inflammatory diseases, the availability of Gobivaz® signals expanded treatment access and increased competitive pressure on pricing, ultimately benefiting patients and healthcare providers seeking sustainable treatment solutions. The partnership between Alvotech and Advanz Pharma exemplifies how collaborative commercial strategies can accelerate the transition from reference biologics to affordable biosimilar alternatives across diverse geographic markets.

Alvotech’s broader pipeline includes eight additional disclosed biosimilar candidates targeting autoimmune disorders, ophthalmologic conditions, osteoporosis, respiratory disease, and oncology. The company maintains a network of strategic commercial partnerships spanning the United States, Europe, Japan, China, and multiple Asian, African, and Latin American territories, positioning it as a significant player in the global biosimilar development landscape.