- In July 2025, Teva Pharmaceuticals and Alvotech announced that the U.S. FDA granted interchangeability status for SELARSDI (ustekinumab-aekn) with Stelara (ustekinumab). This approval allows pharmacy-level substitution without prescriber intervention, marking a major step forward in biosimilar acceptance and increasing access to cost-effective treatment options for autoimmune conditions such as psoriasis and Crohn’s disease
- In July 2025, Johnson & Johnson submitted a U.S. FDA application seeking approval of Stelara (ustekinumab) for the treatment of pediatric Crohn’s disease. This move aims to expand the drug’s therapeutic indications and offer a vital treatment alternative for younger patients with inflammatory bowel disease
- In July 2025, Biocon Biologics and Yoshindo announced a collaboration to expand access to a ustekinumab biosimilar in Japan. This partnership aims to address the rising demand for cost-effective biologic treatments and support broader healthcare affordability in Japan’s chronic inflammatory disease segment
- In July 2025, Bio-Thera Solutions and Hikma Pharmaceuticals received U.S. FDA approval for Starjemza (ustekinumab-hmny), a biosimilar referencing Stelara. This approval signifies a major milestone for both companies, allowing broader access to biosimilar therapies in the U.S. market and fostering competition
- In July 2025, Celltrion announced FDA approval of an additional presentation of Steqeyma (ustekinumab-stba), specifically tailored for pediatric dosing flexibility. This new presentation enhances treatment personalization for younger patients with autoimmune conditions, expanding access to Celltrion’s biosimilar therapy in the U.S.
- In July 2025, a Pharmaceutical Technology report covered the FDA approval of SELARSDI, noting its interchangeable designation with Stelara as a landmark event in the biosimilars industry. The article highlighted the significance of this approval in enhancing affordability and streamlining access to critical biologics for U.S. patients
- In July 2024, Celltrion announced that Health Canada granted approval for its new drug submission (NDS) for Steqeyma (development name CT-P43), a biosimilar designed for treating autoimmune diseases. This biosimilar is modeled after Stelara, expanding treatment options for patients with conditions such as psoriasis and Crohn's disease. The approval represents a significant milestone for Celltrion, enhancing access to effective therapies for managing autoimmune disorders in Canada
