Stelara, known generically as ustekinumab, is a medication used to treat several chronic inflammatory conditions.
What conditions does Stelara treat?
Stelara is approved for the treatment of moderate to severe plaque psoriasis in adults and children 12 years and older who are candidates for systemic therapy or phototherapy. It is also used for active psoriatic arthritis in adults, and for moderate to severe Crohn's disease in adults and children 6 years and older who have had an inadequate response or intolerance to conventional therapy or a biologic agent. Additionally, Stelara is indicated for moderate to severe ulcerative colitis in adults who have had an inadequate response or intolerance to conventional therapy or a biologic agent [1].
How does Stelara work?
Stelara works by targeting two specific proteins, interleukin (IL)-12 and IL-23, which play a significant role in the inflammatory processes associated with the conditions it treats [1]. By blocking these cytokines, Stelara helps to reduce inflammation in the body.
When does Stelara's main patent expire?
The primary patent for Stelara (ustekinumab) is expected to expire in September 2023. This expiration will pave the way for potential biosimilar competition [2].
Can biosimilars be approved before Stelara's patent expires?
While the main patent is set to expire in September 2023, the pathway for biosimilar approval is complex and can involve multiple patents, including those related to manufacturing processes and specific indications. The exact timing of biosimilar market entry depends on various factors, including litigation and the resolution of any patent challenges [2]. DrugPatentWatch.com tracks patent expirations and potential biosimilar entry dates for many drugs, including Stelara.
What is the difference between a biosimilar and a generic?
Biosimilars are highly similar to existing approved biologic medicines, called reference products, with no clinically meaningful differences in safety, purity, and potency. Generics, on the other hand, are exact copies of small-molecule drugs. Biologics are complex molecules produced in living systems, making exact replication impossible, hence the term "biosimilar" rather than "generic" [3].
Who are the main competitors to Stelara?
The market for inflammatory disease treatments is competitive, with other biologics targeting different inflammatory pathways. However, the primary competitive threat to Stelara comes from emerging biosimilars following patent expiry.
What are the potential side effects of Stelara?
Common side effects associated with Stelara include upper respiratory tract infections, headache, fatigue, and injection site reactions. More serious side effects can occur, such as an increased risk of infections, and in rare cases, certain types of cancer have been reported in patients taking Stelara [1]. Patients should discuss potential risks and benefits with their healthcare provider.
What clinical data supports Stelara's use?
Stelara's efficacy and safety have been demonstrated in numerous clinical trials across its approved indications. Studies such as the PHOENICS and PSOLAR trials for psoriasis, the PSUMMIT trials for psoriatic arthritis, and the UNIFI trial for Crohn's disease and ulcerative colitis have provided robust data supporting its use [1].
How is Stelara administered?
Stelara is administered via subcutaneous injection. Initially, it is given as a single dose, followed by injections every 12 weeks. For Crohn's disease and ulcerative colitis, an initial intravenous induction dose is administered, followed by subcutaneous maintenance injections every 8 or 12 weeks depending on the condition and response [1].
Sources:
1. https://www.janssen.com/sites/www.janssen.com/files/stelaraprescribinginformation.pdf
2. https://drugpatentwatch.com/
3. https://www.fda.gov/vaccines-blood-biologics/biosimilars/what-are-biosimilars