Alvotech and Advanz Pharma Secure EC Approval for First Simponi Biosimilar Gobivaz
Alvotech and Advanz Pharma have received marketing authorisations from the European Commission (EC) for Gobivaz, the first biosimilar to Simponi (golimumab) to be approved in the European Economic Area (EEA).
The decision marks a significant step in broadening access to advanced biologic therapies for people living with immune-mediated inflammatory diseases across Europe.
The EC authorisations cover Gobivaz in two strengths – 50 mg/0.5 mL and 100 mg/mL – and in both pre-filled syringe presentations with a passive needle safety guard and autoinjector formats.
These options are designed to support ease of use and flexibility for patients and healthcare professionals, particularly in long-term, self-administered treatment settings.
Gobivaz has been approved for a wide range of indications. In adults, it is authorised for the treatment of rheumatoid arthritis in combination with methotrexate, psoriatic arthritis with or without methotrexate, axial spondyloarthritis and ulcerative colitis.
The approval also extends to paediatric care: Gobivaz can be used in children aged two years and older with juvenile idiopathic arthritis, again in combination with methotrexate. Together, these indications reflect the broad clinical role that golimumab-based therapies play in managing chronic immune-mediated conditions.
This milestone represents the second biosimilar to receive approval through the partnership between Alvotech and Advanz Pharma.
The Chairman and Chief Executive Officer of Alvotech noted that the EC decision further strengthens the commercial presence the company is building in Europe. As the first biosimilar to Simponi (golimumab) in the region, Gobivaz is positioned as a key part of Alvotech’s strategy to expand access to high-quality biologic medicines for patients with immune-mediated diseases, while delivering tangible value to healthcare systems under pressure to manage rising biologics spend.
The Chief Executive Officer of Advanz Pharma also welcomed the EC approval, describing it as an important milestone in the company’s collaboration with Alvotech. Expanding access to high-quality biosimilars, they emphasised, sits at the heart of Advanz Pharma’s mission.
With Gobivaz now authorised, the company can offer patients and clinicians across Europe a valuable new treatment option in an established therapeutic class, potentially improving access and affordability in multiple disease areas.
Under the terms of the agreement between the two companies, Alvotech is responsible for the development and commercial supply of Gobivaz, while Advanz Pharma holds the registration and exclusive commercialisation rights in the EEA and the United Kingdom.
This division of responsibilities combines Alvotech’s biosimilar development and manufacturing expertise with Advanz Pharma’s commercial infrastructure and market reach across European healthcare systems.
The EC’s decision was based on the totality of evidence generated for Gobivaz, including positive clinical and pharmacokinetic studies designed to demonstrate biosimilarity to the reference product, Simponi.
These data supported the conclusion that Gobivaz matches the reference medicine in terms of quality, safety and efficacy, providing regulators and clinicians with confidence in its use across all approved indications.
In conclusion
The approval of Gobivaz as the first Simponi (golimumab) biosimilar in the EEA marks a notable advance for both companies and for patients living with immune-mediated diseases.
With multiple strengths, user-friendly delivery options and a broad set of adult and paediatric indications, Gobivaz is set to play a meaningful role in treatment pathways.
At the same time, its entry into the market underlines the growing importance of biosimilars in supporting sustainable healthcare systems, where high-quality biologic therapies can be made more widely accessible without compromising standards of care.
News Credits: Gobivaz approved across Europe as first Simponi biosimilar
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