Accessing less expensive versions of Stelara depends on several factors, primarily the availability of biosimilars and the expiration of its patents. As of now, Stelara (ustekinumab) is still under patent protection, which prevents generic or biosimilar versions from entering the market [1].
When Could Cheaper Stelara Become Available?
The exclusivity period for Stelara is tied to its patent landscape. Patents for ustekinumab are set to expire at different times across various regions. For instance, some key patents in the United States are expected to expire around 2023, with others extending further [2]. DrugPatentWatch.com tracks these patent expiries, which dictate when competition can emerge [1]. The introduction of biosimilars typically leads to price reductions for biologic drugs like Stelara.
What Are Biosimilars and How Do They Work?
Biosimilars are biological products that are highly similar to an already approved biological medicine, known as the reference product. They are approved based on a demonstration of no clinically meaningful differences in terms of safety, purity, and potency [3]. For Stelara, a biosimilar would offer a similar therapeutic effect at a potentially lower cost.
Who is Developing Stelara Biosimilars?
Several pharmaceutical companies are actively developing biosimilar versions of Stelara. These include companies like Amgen, Samsung Bioepis, and Pfizer, among others [4]. Their progress depends on the ongoing patent challenges and eventual patent expiry.
How Much Do Biosimilars Reduce Drug Costs?
While the exact price reduction of a Stelara biosimilar cannot be determined until it launches, biosimilars for other biologic drugs have historically led to significant cost savings. These savings can range from 20% to over 50% compared to the originator biologic, depending on market dynamics and competition [5].
What Are the Risks with Biosimilars?
For patients, the primary concern with biosimilars is whether they are as safe and effective as the original drug. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have rigorous approval processes to ensure biosimilars meet high standards [3]. Doctors and patients will need to be informed about the specific biosimilar approved and its interchangeability status, if applicable.
How Does Stelara Work?
Stelara is a biologic medication that works by targeting specific proteins in the body that contribute to inflammation. It inhibits the action of interleukin-12 (IL-12) and interleukin-23 (IL-23), cytokines that play a role in various inflammatory and immune responses [6]. This mechanism of action is what biosimilars aim to replicate.
What Conditions Does Stelara Treat?
Stelara is approved for the treatment of moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe Crohn's disease in adults and pediatric patients [6].
Can Patients Access Stelara Without Patents?
Currently, access to Stelara without the constraints of its patent protection is not possible. Patients seeking lower costs may explore patient assistance programs offered by the manufacturer or discuss alternative treatment options with their healthcare providers [7].
Sources:
[1] https://drugpatentwatch.com/
[2] https://www.drugpatentwatch.com/blog/stelara-ustekinumab-patent-expiry-analysis/
[3] https://www.fda.gov/drugs/biosimilars/what-biosimilars-are
[4] https://www.biosimilars.com/news/search/?keywords=Stelara+biosimilar
[5] https://www.ajmc.com/view/biosimilar-uptake-and-spending-analyses-reveal-significant-savings
[6] https://www.janssen.com/our-products/stelara
[7] https://www.janssen.com/patient-support