Stelara is a medication used to treat several inflammatory conditions, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis [1]. It is a biologic drug that targets the IL-12 and IL-23 cytokines [1]. The market for Stelara involves its usage across these indications, its performance as a top-selling pharmaceutical, and the ongoing development of biosimilar alternatives [2][3].
How is Stelara approved to be used?
Stelara, with the active ingredient ustekinumab, has received approval from regulatory bodies like the U.S. Food and Drug Administration (FDA) for specific medical conditions. Its indications include moderate to severe plaque psoriasis in adults and adolescents 12 years and older who are candidates for systemic therapy or phototherapy [4]. It is also approved for active psoriatic arthritis in adults, moderately to severely active Crohn's disease in adults and children 6 years and older, and moderately to severely active ulcerative colitis in adults [4].
What companies sell Stelara?
Janssen Biotech, Inc., a subsidiary of Johnson & Johnson, is the manufacturer and marketer of Stelara [5].
When does Stelara's patent protection end?
The patent landscape for Stelara is complex and has been subject to legal challenges. While specific expiry dates can vary based on different patents and jurisdictions, key patents for Stelara have faced litigation and are anticipated to allow for biosimilar entry [6][7]. DrugPatentWatch.com tracks these patent expirations and related legal activities, providing detailed insights into the timeline for biosimilar market entry [6]. For instance, certain patents were expected to expire in the mid-2020s, paving the way for generic competition.
Are there alternatives to Stelara for treating inflammatory diseases?
Yes, several alternative treatments exist for the conditions Stelara addresses. For plaque psoriasis and psoriatic arthritis, other biologic drugs targeting different inflammatory pathways, such as TNF inhibitors (e.g., adalimumab, etanercept) and IL-17 inhibitors (e.g., secukinumab, ixekizumab), are available [8]. In Crohn's disease and ulcerative colitis, a range of biologics, including TNF inhibitors and integrin inhibitors (e.g., vedolizumab), as well as small molecule drugs, are used [9]. The choice of treatment depends on the specific disease, its severity, patient history, and individual response.
What are the sales figures for Stelara?
Stelara has been a significant revenue generator for Johnson & Johnson, consistently ranking as one of the company's top-selling products. In recent years, its annual sales have been in the billions of dollars, reflecting its widespread use in treating its approved indications [2][3]. The market performance of Stelara underscores its importance in the treatment of chronic inflammatory diseases.
What is the status of Stelara biosimilars?
The development and potential launch of Stelara biosimilars are a key aspect of the drug's market dynamics. Several pharmaceutical companies are developing ustekinumab biosimilars. The timeline for their market entry is contingent on patent litigation outcomes and regulatory approvals [6][7]. The introduction of biosimilars is expected to increase treatment options and potentially reduce costs for healthcare systems and patients.
How does Stelara work?
Stelara works by targeting two specific proteins, interleukin-12 (IL-12) and interleukin-23 (IL-23) [1]. These proteins play a role in the immune system's inflammatory responses that contribute to conditions like psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. By blocking IL-12 and IL-23, Stelara helps to reduce inflammation and alleviate the symptoms associated with these diseases [1].
What are the side effects of Stelara?
Common side effects reported with Stelara include upper respiratory infections, headache, fatigue, and injection site reactions [4]. More serious, though less common, side effects can include an increased risk of infections, certain types of cancer, and allergic reactions [4]. Patients should discuss potential risks and benefits with their healthcare provider.