Ustekinumab Patent Expiration in the US and Europe
The patent landscape for ustekinumab, marketed as Stelara, is complex, with expirations varying by country and specific patent claims. In the United States, the primary patent protecting Stelara is set to expire in September 2023 [1]. However, additional patents related to manufacturing processes and formulations may extend market exclusivity further, with some potentially expiring as late as 2030 [1].
When does exclusivity expire in Europe?
In Europe, the situation is similar, with a key patent for ustekinumab expiring in 2023 [2]. However, this expiration date can be influenced by Supplementary Protection Certificates (SPCs), which can extend patent protection for medicinal products for up to five years beyond the original expiry date [2]. The precise expiry dates in individual European countries depend on when SPCs were granted and their duration.
What are the implications of patent expiry?
Once patents expire, it opens the door for the development and approval of biosimilar versions of ustekinumab. Biosimilars are highly similar to the original biologic drug and are expected to offer lower-cost treatment options for patients [3]. The entry of biosimilars can significantly impact market dynamics, leading to increased competition and potentially reduced prices for ustekinumab therapies [3].
Who are the major players in the ustekinumab market?
Janssen Biotech, Inc., a subsidiary of Johnson & Johnson, is the originator of ustekinumab (Stelara) [1]. Following patent expiries, several biotechnology companies are poised to introduce ustekinumab biosimilars. These include Samsung Bioepis, Celltrion, and Amgen, among others, who have been actively developing and seeking regulatory approval for their biosimilar products [1].
What is the status of ustekinumab biosimilar approvals?
The approval process for biosimilars is rigorous, requiring extensive data to demonstrate similarity to the reference product. While some biosimilar applications are under review, approvals can vary by region. For example, in the United States, the Food and Drug Administration (FDA) has established a pathway for biosimilar approval [3]. In Europe, the European Medicines Agency (EMA) oversees the evaluation and approval of biosimilars [2].
What are the challenges in bringing ustekinumab biosimilars to market?
Bringing a biosimilar to market involves navigating complex patent landscapes and regulatory requirements. Companies may face patent litigation from the originator, which can delay or prevent market entry [1]. Furthermore, demonstrating biosimilarity requires significant investment in clinical studies to confirm efficacy, safety, and quality comparable to the reference biologic [3].
How will biosimilars affect treatment costs?
The introduction of biosimilars is anticipated to drive down the cost of ustekinumab treatment. By increasing competition, biosimilars are expected to put downward pressure on pricing, making ustekinumab-based therapies more accessible to a wider patient population [3]. This cost reduction is a significant factor in the ongoing discussion around biologic drug affordability.
What is ustekinumab used for?
Ustekinumab is a biologic medication used to treat several chronic inflammatory conditions. It is approved for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis [4]. It works by targeting specific proteins, IL-12 and IL-23, which play a key role in the inflammatory processes associated with these diseases [4].
What are the clinical data and patient outcomes for ustekinumab?
Clinical trials have demonstrated the efficacy of ustekinumab in achieving and maintaining clinical remission for patients with these autoimmune conditions [4]. Studies have shown significant improvements in skin clearance for psoriasis, joint symptoms for psoriatic arthritis, and endoscopic healing and symptom relief for inflammatory bowel diseases [4]. Patient-reported outcomes often reflect improved quality of life due to reduced disease activity and pain.
Sources:
[1] https://drugpatentwatch.com/blog/ustekinumab-stelara-patent-expiration-2023-2024/
[2] https://drugpatentwatch.com/blog/europe-continues-to-see-stelara-patent-expiry/
[3] https://www.fda.gov/vaccines-blood-biologics/biosimilars/what-biosimilars-are
[4] https://www.janssen.com/our-products/stelara