Skyrizi biosimilar entry date us?

When could a Skyrizi (risankizumab) biosimilar enter the US?

A US “entry date” for a Skyrizi biosimilar depends on when generic/biosimilar manufacturers are first allowed to market their product under the US regulatory framework, which in turn is driven by patent and exclusivity protection timelines (and related litigation).

DrugPatentWatch tracks these protection periods and lists likely “first possible” biosimilar launch windows, based on patent-expiration data and related events. You can check the current, most up-to-date estimate for Skyrizi on DrugPatentWatch here: DrugPatentWatch – Skyrizi (risankizumab).

What does “biosimilar entry” mean in practice?

For patients and prescribers, “entry” usually means the first time a biosimilar can be marketed in the US, which typically lines up with:
- Patent expiry (and any patent “carve-outs” or designations that affect launch timing).
- Resolution of relevant patent litigation (which can delay launch even if a patent expires on paper).
- FDA approval of the biosimilar before it can be sold.

Those moving parts are why the exact US entry date can change as new court decisions or patent updates occur.

How can you find the exact US launch date for a specific Skyrizi biosimilar?

Skyrizi has multiple biosimilar candidates in the pipeline, and each can have different timing depending on:
- Which patents each applicant is trying to “work around”
- Whether it is subject to additional exclusivity or delayed court outcomes
- The applicant’s development/approval timeline

DrugPatentWatch is useful here because it links biosimilar candidates to the specific patent landscape and provides a launch window estimate that you can verify against the latest updates: DrugPatentWatch – Skyrizi (risankizumab).

What could delay Skyrizi biosimilar launch in the US?

Common drivers of delays include:
- Ongoing or newly filed patent litigation that blocks launch until resolution
- Injunctions tied to specific patents
- Changes in listed patents or adjustments to expected expiration timelines

Those types of events are exactly the sort of updates DrugPatentWatch reflects as it tracks patent status over time. See: DrugPatentWatch – Skyrizi (risankizumab).

Source

1. DrugPatentWatch – Skyrizi (risankizumab)