Alvotech Launches Gobivaz®, the World’s First Simponi® Biosimilar, Across Europe In Partnership With Advanz Pharma

Alvotech, a global biotechnology company known for developing and manufacturing biosimilar medicines, has announced that the European launch of its biosimilar Gobivaz® (golimumab) is now underway. Gobivaz, also referred to as AVT05, is Alvotech’s biosimilar version of Simponi® (golimumab) and is available in both a prefilled syringe and an autoinjector. With this launch, Gobivaz becomes the first biosimilar to Simponi to be introduced anywhere in the world. In Europe, the product is being commercialized exclusively through Alvotech’s partner, Advanz Pharma.

In the United Kingdom, the introduction of Gobivaz is supported by an NHS England tender award. This award provides a structured framework for how the product can be adopted across NHS services. It also reflects the NHS’s ongoing focus on improving patient access to reliable and cost-effective biologic therapies used for treating immune-mediated inflammatory diseases.

Across other countries in the European Economic Area (EEA), Gobivaz will become available progressively as each nation completes its pricing and reimbursement procedures. This step-by-step rollout ensures that market access aligns with individual country regulations and healthcare system requirements.

Robert Wessman, Chairman and Chief Executive Officer of Alvotech, expressed his support for the product’s entry into clinical practice across Europe. He noted that Gobivaz, as the first approved biosimilar to Simponi, provides an important treatment option for patients. He also emphasized that the NHS England tender supports Alvotech’s mission to broaden access to high-quality biologic medicines.

The approval of Gobivaz was based on a full range of analytical, pre-clinical, and clinical studies demonstrating that it matches the reference product, Simponi, in terms of quality, safety, and efficacy. Gobivaz is offered in the same dosage forms and presentations as Simponi and is manufactured at Alvotech’s state-of-the-art facility in Iceland.