Marketing Authorization Confirmed in EU

The European Union Executive Committee approved the EU-wide marketing authorization for Usrenty (ustekinumab) on September 17, 2025. The Committee for Medicinal Products for Human Use (CHMP) under the EMA had previously adopted a positive opinion on July 24, and the approval process was completed without a separate advisory committee vote. The marketing authorization holder is Biosimilar Collaborations Ireland Limited, a grandchild company of Biocon Limited. Usrenty is now in the Approval stage, and sales will be possible after price and reimbursement listings at the national level.

Drug and Clinical Basis

Usrenty is a biosimilar to Stelara (ustekinumab), a fully human IgG1κ monoclonal antibody that blocks the p40 subunit shared by interleukin-12 and interleukin-23. Indications include moderate to severe plaque psoriasis in patients aged six years and older, adult psoriatic arthritis, and moderate to severe Crohn’s disease in adults who have not adequately responded to prior therapies or tumor necrosis factor-alpha (TNF-α) inhibitors. The development program included a Phase 1 trial (BM12H-NHV-01-G-01) in healthy volunteers and a Phase 3 trial (BM12H-PSO-03-G-02) in plaque psoriasis patients. The EMA extrapolated the evidence of structural, purity, and biological activity similarity, as well as pharmacokinetics and equivalence in efficacy and safety from Phase 3, to all indications.

A Price-Driven Market

Stelara, the reference product owned by Janssen-Cilag International, was approved in the EU on January 15, 2009, and generated approximately $6.7 billion in U.S. sales in 2024. The European ustekinumab market is estimated to be around $2.7 billion just before patent expiry, representing a major biosimilar conversion opportunity. However, Usrenty will compete with Uzpruvo, launched in July 2024 following EU approval in January 2024, as well as Wezlana, Pyzchiva, Steqeyma, Otulfi, and Imuldosa. Therefore, market share will depend more on tender pricing, supply stability, simultaneous availability of intravenous and subcutaneous formulations, and adoption in hospital prescribing patterns across countries rather than approval alone.

Commercialization Investment Implications

The standard therapy competitive set includes TNF-α inhibitors such as adalimumab (Humira) and infliximab (Remicade), as well as IL-23 inhibitors like risankizumab (Skyrizi) and guselkumab (Tremfya). Usrenty is not a novel mechanism drug but a product designed to convert the established demand for Stelara at a lower price, making price erosion and procurement competition more critical than clinical failure risk. Biocon can leverage its European sales infrastructure acquired through the Viatris biosimilars business, but late entry may bring discounting pressures and early entrants' contract advantages that limit profitability. This deal did not involve new licensing agreements, upfront payments, milestones, or royalties, and future national launches and reimbursement speed will be key indicators of real value creation.