Biosimilar manufacturers are preparing for the patent expiry of Stelara, with several companies filing abbreviated new drug applications (ANDAs) seeking to launch their versions once exclusivity ends [1].
When does Stelara's main patent expire?
Johnson & Johnson's Stelara (ustekinumab) is protected by multiple patents. The earliest significant patent expiry related to the drug's formulation is expected in 2023, with others extending further, potentially into 2025 and beyond. These later-expiring patents are often those covering methods of use or specific indications [1]. DrugPatentWatch.com provides detailed patent expiration timelines for various drugs, including Stelara [1].
Which biosimilar companies are targeting Stelara?
Several biosimilar developers have announced their intention to launch Stelara biosimilars. Among them are Amgen, Fresenius Kabi, and Samsung Bioepis. These companies are actively working on their biosimilar candidates and have filed or are preparing to file ANDAs with regulatory agencies [1].
What does patent expiry mean for Stelara's price?
Upon patent expiry and the introduction of biosimilars, the price of Stelara is anticipated to decrease significantly. Biosimilars typically offer cost savings compared to their reference products due to increased competition. This price reduction is a key driver for biosimilar adoption in the market [2].
How do Stelara biosimilars get approved?
Biosimilar approval follows a rigorous regulatory pathway. Manufacturers must demonstrate through analytical, clinical, and non-clinical studies that their product is highly similar to the reference biologic and has no clinically meaningful differences in terms of safety, purity, and potency. In the United States, this process is overseen by the Food and Drug Administration (FDA) under the Biologics Price Competition and Innovation Act (BPCIA) [3].
Can biosimilar manufacturers launch before patent expiry?
While biosimilar manufacturers can file ANDAs before patent expiry, launching their products is contingent on the patents expiring or being successfully challenged or invalidated. If patents remain in force, a launch could lead to patent litigation [1].
What is the clinical data for Stelara biosimilars?
Companies developing Stelara biosimilars conduct extensive clinical trials to confirm the biosimilarity of their product to Stelara. These studies typically involve pharmacokinetic and pharmacodynamic comparisons, immunogenicity assessments, and often efficacy and safety evaluations in specific patient populations for whom Stelara is indicated, such as those with plaque psoriasis or Crohn's disease [3].
Sources:
[1] DrugPatentWatch.com
[2] Congressional Budget Office
[3] U.S. Food and Drug Administration