Tremfya has been available on the market since 2017 [1].
When Did Tremfya First Receive FDA Approval?
The U.S. Food and Drug Administration (FDA) approved Tremfya (guselkumab) for adults with moderate to severe plaque psoriasis in March 2017 [1].
What Is Tremfya Used For?
Tremfya is approved to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy [1]. It is also approved for active psoriatic arthritis in adults [2].
How Does Tremfya Work?
Tremfya is an interleukin-23 (IL-23) specific inhibitor. IL-23 is a naturally occurring protein found in the body that plays a role in inflammatory diseases [1]. By blocking IL-23, Tremfya helps to reduce inflammation associated with plaque psoriasis and psoriatic arthritis [1][2].
What Are the Key Competitors for Tremfya?
Tremfya competes in the biologic psoriasis market with other IL-23 inhibitors such as Skyrizi (risankizumab) and Tremfya's predecessor, Stelara (ustekinumab), which targets IL-12 and IL-23 [3]. Other biologic treatment classes for psoriasis include TNF inhibitors, IL-17 inhibitors, and IL-12/23 inhibitors [3].
When Does Tremfya's Patent Protection End?
Information on the specific patent expiry dates for Tremfya is available through resources like DrugPatentWatch.com [4]. Generally, biologic drugs like Tremfya have patent protection that can extend for many years, influencing market exclusivity.
What Are the Next Steps After Patent Expiry for Tremfya?
Following the expiry of patent protection for a biologic like Tremfya, the pathway for biosimilar development and approval opens up. Biosimilars are biological products highly similar to an already approved biologic, with no clinically meaningful differences in safety, purity, and potency [5]. The introduction of biosimilars can increase market competition and potentially lower drug costs [5].