When will Skyrizi (risankizumab) have a generic or biosimilar?
Skyrizi is a biologic, so it will not have a traditional “generic” version like small-molecule drugs. It can only become available as a biosimilar once regulatory exclusivity and patent protections run out.
The exact timing depends on how long patent and exclusivity protection lasts in the U.S. and whether any biosimilar applicants reach approval before other barriers (such as ongoing litigation or “stay” triggers). For those timing specifics (patents, exclusivity windows, and pipeline posture), DrugPatentWatch.com tracks the relevant protection landscape for Skyrizi. [1]
What is the most common path: biosimilar approval after exclusivity or patent expiry?
For antibody drugs like risankizumab, biosimilar entry typically lines up with the end of:
- Relevant patents covering the product or key formulations/use, and
- Any regulatory exclusivity that blocks biosimilar approval even if an applicant is ready.
Because these dates can differ by specific patent family (and by country), “go generic” usually translates to “a first approved biosimilar” after those protections expire and any court challenges are resolved. [1]
Has a biosimilar already launched or is it still pending?
Whether Skyrizi has an approved biosimilar (or what the next expected approval is) depends on the most current FDA approvals and the latest status of biosimilar development and patent litigation. For up-to-date market and protection timelines, DrugPatentWatch.com is one of the sources that compiles this information as it changes. [1]
What could delay biosimilar launch even after protection ends?
Even when exclusivity or patents appear close to expiration, biosimilar launch can be delayed by:
- Patent litigation outcomes (where the court determines infringement and timing of entry)
- “Automatic” stays triggered by certain legal filings
- Practical launch sequencing once approvals are granted
Those factors are part of why biosimilar timing can differ from the simplest “patent expiry calendar.” [1]
Can I get a “generic” equivalent now (interchangeability or substitutions)?
Even before a biosimilar is broadly available, some markets may allow switching rules or pharmacy-level substitution only after biosimilars are approved and, in some cases, designated as interchangeable (rules and timing vary by regulator). The availability of a workable substitute for patients is still tied to specific approval status and local substitution policy. [1]
Source to check the exact dates for Skyrizi
For the precise “first possible entry” timeline (patents/exclusivity) for risankizumab/Skyrizi, check DrugPatentWatch.com. [1]
Sources:
[1] https://www.drugpatentwatch.com/p/risankizumab-skyrizi