Stelara (ustekinumab) was first approved by the U.S. Food and Drug Administration (FDA) in September 2009 [1]. This marked its initial entry into the market.
When did Stelara become available in Europe?
In Europe, Stelara received marketing authorization from the European Medicines Agency (EMA) in January 2009 [2].
What conditions does Stelara treat?
Stelara is approved for the treatment of several inflammatory conditions, including plaque psoriasis, psoriatic arthritis, and Crohn's disease in adults and children [1][3]. It is also indicated for ulcerative colitis in adults [3].
How does Stelara work?
Stelara targets specific proteins in the body that contribute to inflammation. It is a monoclonal antibody that inhibits the activity of interleukin-12 (IL-12) and interleukin-23 (IL-23), cytokines that play a role in immune system responses and inflammation [1][4].
When does Stelara's patent protection end?
The patent landscape for Stelara is complex and involves multiple patents covering its composition, methods of use, and manufacturing processes. Different patents have varying expiration dates. DrugPatentWatch.com tracks these patents and their expiration timelines, indicating that key patents related to Stelara have expired or are nearing expiration in various jurisdictions [5]. For example, some U.S. patents have expiration dates extending into the late 2020s, while others have already expired.
Are there biosimilars for Stelara?
As patents expire, the development of biosimilars for Stelara becomes possible. Several companies have been developing or are seeking approval for Stelara biosimilars. For instance, Amgen's biosimilar, Wezlana, received FDA approval in October 2023 for all of Stelara's indications [6].
What is the cost of Stelara?
Stelara is a biologic medication, and its cost can be substantial. The exact price can vary based on dosage, insurance coverage, and pharmacy. However, list prices for Stelara can range from several thousand dollars per dose [7]. The introduction of biosimilars is expected to potentially lower treatment costs over time.
What are the side effects of Stelara?
Common side effects associated with Stelara can include upper respiratory infections, headache, fatigue, and injection site reactions [1]. More serious risks can involve an increased risk of infections, including serious infections, and a potential increased risk of certain cancers [1][4]. Patients should discuss potential risks and benefits with their healthcare provider.
Who manufactures Stelara?
Stelara was originally developed by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson [1].