Biosimilar manufacturers are actively preparing for the patent expiry of Stelara (ustekinumab) by developing and seeking approval for their own versions of the drug. These companies aim to introduce lower-cost alternatives once Stelara's market exclusivity ends.
When does Stelara's main patent expire?
The primary patents protecting Stelara are set to expire around September 2023 for some formulation and use patents, with manufacturing and composition patents extending further, potentially into 2024 and later [1][2]. DrugPatentWatch.com tracks these patent landscapes, noting that specific expiry dates can vary based on different patent types and regional filings [1].
How are biosimilar companies preparing for Stelara's patent expiry?
Companies like Amgen, Samsung Bioepis, and Alvotech have been developing biosimilar versions of Stelara. This preparation involves extensive clinical trials to demonstrate the biosimilar's analytical, non-clinical, and clinical comparability to the reference product, Stelara [3][4]. Following successful trials, they file marketing authorization applications with regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) [3][4].
What does it take to get a Stelara biosimilar approved?
Approval requires demonstrating that the biosimilar is highly similar to Stelara in terms of its physicochemical properties, biological activity, and clinical efficacy and safety [3][4]. This often involves a robust data package that includes results from comparative studies, such as pharmacokinetic and pharmacodynamic studies, and potentially a clinical trial in patients [3][4].
What is the difference between a biosimilar and a generic drug?
Biosimilars are for biologic medications, which are complex molecules produced from living organisms, while generic drugs are for small-molecule chemical drugs. Due to the complexity of biologics, biosimilars are not exact copies of the reference product but are highly similar with no clinically meaningful differences in safety, purity, and potency [5].
How might Stelara biosimilars impact the market?
The introduction of Stelara biosimilars is expected to increase competition, potentially leading to lower prices for ustekinumab treatment and expanding patient access to this therapy [3]. This is a common pattern observed with other biologic biosimilars that have entered the market [5].
Who are the main companies developing Stelara biosimilars?
Key companies developing Stelara biosimilars include Amgen, with its product ABP 654, and Samsung Bioepis, with SB17 [3][4]. Alvotech is also a significant player in this space [4].
What are the potential challenges for Stelara biosimilar manufacturers?
Biosimilar manufacturers face challenges including the complex and lengthy development process, the cost of clinical trials, and navigating patent litigation. Companies may also encounter market access hurdles and the need to educate physicians and patients about biosimilarity [3][5].
How does Stelara work, and what is it used for?
Stelara is a biologic medication that targets the interleukin-12 and interleukin-23 cytokines. It is approved for treating moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis [6].
Sources:
- DrugPatentWatch.com. "Ustekinumab Patent Expiry." https://drugpatentwatch.com/
- DrugPatentWatch.com. "Stelara Patent Landscape." https://drugpatentwatch.com/
- Amgen. "Amgen Announces FDA Acceptance of Biosimilar Application for ABP 654, a Proposed Biosimilar to Stelara® (ustekinumab)." https://www.amgen.com/
- Samsung Bioepis. "Samsung Bioepis Submits Marketing Authorisation Application for SB17, its Proposed Biosimilar to Stelara® (ustekinumab), to the European Medicines Agency." https://www.samsungbioepis.com/
- FDA.gov. "What is a Biosimilar?" https://www.fda.gov/
- Janssen Biotech, Inc. "STELARA® (ustekinumab)." https://www.janssen.com/