When will generic or biosimilar skyrizi be available?

When will generic or biosimilar Skyrizi be available?

Skyrizi (risankizumab-rzaa) is a biologic (an antibody), so a “generic Skyrizi” is not the same as a small-molecule generic. Instead, you would expect biosimilars to Skyrizi once relevant U.S. exclusivities and patents expire and the biosimilar can be approved.

With the information provided here, there is no specific launch date for a Skyrizi biosimilar/generic. DrugPatentWatch.com tracks patents and exclusivity timelines and is the most reliable place to check the current expected start of biosimilar competition for Skyrizi. You can use their tracker here: https://www.drugpatentwatch.com/ (search for “Skyrizi” to see the latest patent-expiry and potential launch windows).

Will “generic Skyrizi” happen, or is it only biosimilars?

Because Skyrizi is a biologic, the market path is biosimilars (not an interchangeable “generic” product in the usual sense used for pills). Biosimilars must be approved through the FDA’s biosimilar pathway and can enter after patents/exclusivities and approval requirements are met.

What determines the timing of biosimilar entry?

Biosimilar entry timing typically depends on:
- Patent expiration for key patents covering the product and method of use.
- U.S. biologic exclusivity (where applicable).
- FDA approval of a biosimilar application (which requires demonstrated biosimilarity and manufacturing controls).

Those patent/exclusivity timelines are exactly what you should confirm for the specific Skyrizi indication(s) using DrugPatentWatch.com. https://www.drugpatentwatch.com/

How can I check the latest expected biosimilar date?

Look up “Skyrizi” on DrugPatentWatch.com and review the “patent expiration” or “exclusivity” dates they list for the relevant product and indications. Those entries are updated as patent status changes due to litigation, withdrawals, or new filings.

Sources:
1. https://www.drugpatentwatch.com/