Johnson & Johnson Secures European Approval for Expanded Indication of Stelara in Pediatric Ulcerative Colitis, Reinforcing Lifecycle Management
Maintaining Approval Through Indication Expansion
Johnson & Johnson (JNJ)'s blockbuster autoimmune disease treatment, Stelara (ustekinumab), has successfully renewed its marketing authorization in Europe through the 53rd revision of the European Medicines Agency (EMA)'s European Public Assessment Report (EPAR). This regulatory update follows the European Medicines Agency (EMA) approval of the Committee for Medicinal Products for Human Use (CHMP) recommendation on June 25, 2026, to expand the indication to include moderate-to-severe active ulcerative colitis in patients aged two years and older. By extending the target patient population to include the pediatric segment, which has significant unmet needs, Johnson & Johnson is effectively defending its market share and preserving the value of its original drug.
Biosimilar Competition and Lifecycle Management Strategy
The substance patent and supplementary protection certificate (SPC) for Stelara in Europe expired on July 20, 2024, leading to a rapidly changing market landscape. Immediately after the patent expiration, on July 22, 2024, Alvotech and STADA launched Uzpruvo, the first Stelara biosimilar in Europe. Subsequently, Celltrion's Steqeyma and Samsung Bioepis' Pyzchiva, along with other strong competitors from Asia, have entered the market. In this environment, Johnson & Johnson is employing a lifecycle management (LCM) strategy by adding new indications to differentiate Stelara from biosimilars.
Defending Revenue and Navigating Generational Transition
Thanks to its potent mechanism of action, which simultaneously targets interleukin-12/23 (IL-12/23), Stelara has generated global revenues of approximately $10.9 billion in 2023 and $10.3 billion in 2024, making it a key revenue driver for Johnson & Johnson's pharmaceutical division. However, with the expiration of the patent barrier, the company anticipates a double-digit decline in sales, starting in the European market. Johnson & Johnson is implementing a two-pronged strategy to defend Stelara's revenue while simultaneously encouraging patients to switch to Tremfya (guselkumab), a more targeted interleukin-23 (IL-23) selective inhibitor.
Shifting Hegemony in the Autoimmune Disease Market
The interleukin inhibitor market, previously dominated by Stelara, has become increasingly competitive with the entry of new players such as AbbVie's Skyrizi (risankizumab) and Novartis' Cosentyx (secukinumab). The expansion of the indication to include pediatric patients not only increases short-term revenue but also reinforces brand trust by demonstrating the long-term accumulation of clinical safety data in the treatment setting. Ultimately, this European approval renewal can be interpreted as a strategic move by Johnson & Johnson to secure the last remaining clinical advantage for its original biologic drug in the market after patent expiration.
The European approval renewal (Revision 53) of Stelara (ustekinumab), a blockbuster autoimmune disease treatment with annual sales of $10 billion, exemplifies the market defense strategy of an originator pharmaceutical company after patent expiration. With the European substance patent expiring in July 2024, followed by the launch of biosimilars such as Alvotech's Uzpruvo and Celltrion's Steqeyma, the expansion of the indication to include ulcerative colitis in patients aged two years and older serves as a clinical tool for defending market share. From a research perspective, the validation of the long-term safety of the IL-12/23 targeting mechanism, initially developed for adults, in a pediatric population provides an important benchmark for the development of future pediatric immuno-oncology and autoimmune drugs. In the medium to long term, the autoimmune disease market is expected to shift towards second-generation IL-23 inhibitors such as AbbVie's Skyrizi or Johnson & Johnson's Tremfya, making Stelara's gradual transition essential for the company's generational change.
Source: EMA (ema)