Alvotech and STADA Get EU Marketing Application Approval for Ustekinumab Biosimilar

What is Ustekinumab?

Ustekinumab is a human monoclonal antibody medication utilized for treating plaque psoriasis, Crohn's disease, psoriatic arthritis, and ulcerative colitis.

The EMA Approval

Acceptance of Marketing Application for AVT06

The European Medicines Agency (EMA) has accepted a Marketing Authorization Application (MAA) for AVT06, a proposed ustekinumab biosimilar from Alvotech and STADA.

Therapeutic Equivalence Demonstrated

The study supporting the application met its primary endpoint, showing therapeutic equivalence between AVT06 and the reference product.

Projected Timeline for Approval

Marketing Authorization Anticipated in Q3 2025

The approval process is anticipated to be finalized in the third quarter of 2025, enabling AVT06 to become the first ustekinumab biosimilar authorized for use in Europe.

Significance of the Approval

Increased Access to Ustekinumab Therapy

The approval of AVT06 is expected to enhance access to ustekinumab therapy for patients suffering from immune-mediated diseases.

Potential Cost Savings

Biosimilars like AVT06 often have lower costs than their reference products, offering potential savings for healthcare systems and patients.