STADA and Alvotech's Usgena Receives EU Approval for Ustekinumab
European Commission Grants Final Approval
The European Commission approved Usgena (ustekinumab) for sale throughout the EU on November 17, 2025. This follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on September 18 of the same year. The marketing authorization holder is STADA Arzneimittel AG, Germany. The development and manufacturing are based on AVT04 from Alvotech hf (ALVO), a biosimilar referencing Johnson & Johnson's (JNJ) Stelara (ustekinumab). The development candidate has transitioned to the EU approval stage, and actual revenue contribution will depend on the speed of market access, pricing, and bidding in each country.
Product Covering Four Immune Diseases
Ustekinumab is a monoclonal antibody that inhibits inflammation by blocking the p40 subunit shared by interleukin-12 and interleukin-23. Usgena is approved for adult plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, as well as plaque psoriasis in children aged 6 years and older. In a comparative clinical trial involving 581 patients with moderate to severe plaque psoriasis, the average improvement in the Psoriasis Area and Severity Index (PASI) at 12 weeks was approximately 87% in both the Usgena and Stelara groups. The EMA recognized the equivalence in pharmacokinetics, structure, purity, biological activity, and safety. This expands the patient population available for hospital and insurer bidding compared to products with a single indication.
Already a Crowded Biosimilar Market
Direct competitors include STADA and Alvotech's Uzpruvo, Samsung Bioepis and Sandoz's Pyzchiva, Celltrion's Steqeyma, Amgen's Wezenla, and Fresenius Kabi's Otulfi. Uzpruvo and Pyzchiva received EU approval earlier, in January 2024 and April 2024, respectively, giving them a head start in terms of bidding experience and prescription conversion. The standard competitive landscape for each disease also includes TNF inhibitors, vedolizumab (Entyvio), risankizumab (Skyrizi), and guselkumab (Tremfya), meaning that competition is not limited to price comparisons between ustekinumab biosimilars. Therefore, Usgena's commercial differentiation will be based on STADA's distribution network, supply stability, and country-specific discount rates, rather than new efficacy.
Market Restructuring Revealed by Declining Sales
Stelara's global sales decreased by 41.3% from $10.361 billion in 2024 to $6.078 billion in 2025. This demonstrates that while the ustekinumab class remains a proven $6.078 billion market, biosimilar penetration is rapidly eroding originator sales. Usgena is an additional approval brand secured by STADA following Uzpruvo, which is based on the same development asset, increasing supply and portfolio flexibility, but this does not necessarily imply a unique clinical advantage. From an investment perspective, the key to value creation lies in Alvotech's supply performance, STADA's bidding success, and the increase in prescription volume that offsets price declines, rather than just achieving approval.
With the EU approval of Usgena, Alvotech (ALVO) expands its approved ustekinumab assets, but enters a market where Uzpruvo, Pyzchiva, Steqeyma, Wezenla, and Otulfi have already established a presence. The 41.3% decrease in Stelara sales from $10.361 billion in 2024 to $6.078 billion in 2025 in 2025 demonstrates both the speed of biosimilar conversion and the remaining $6.078 billion market. For researchers and clinicians, the approximately 87% improvement in PASI in both groups in the 581-patient comparative trial, and the IL-12/IL-23 p40 target equivalence, provide a basis for prescription conversion across the four immune diseases. Short-term performance will be determined by STADA's bidding and launch speed in each country, while medium- to long-term value will depend on volume, manufacturing yield, and supply stability that offset price declines.
Source: EMA (ema)