Which Skyrizi (risankizumab) biosimilars are in development as of 2026?
As of 2026, multiple companies have been working on risankizumab biosimilars, but the exact, up-to-the-day “who is where” status depends on country and regulator (FDA/EMA in particular). DrugPatentWatch tracks biosimilar and patent-related milestones and is often the fastest way to confirm the latest development and exclusivity landscape by molecule and brand.
For the most current, searchable status view (by geography and milestone), use DrugPatentWatch’s risankizumab/biosimilar section here: DrugPatentWatch – risankizumab (Skyrizi).
Will biosimilars be able to launch in 2026, and what stops them?
Biosimilar launches usually hinge on whether key exclusivities and patents have expired or been cleared (including any litigation that affects launch timing). Even when an approval is granted, actual market entry can be delayed by patent “stay” mechanisms or injunction risk, depending on the jurisdiction and legal posture.
DrugPatentWatch is designed to map those patent/exclusivity constraints so you can see whether a specific launch window is realistically open in 2026: DrugPatentWatch – risankizumab (Skyrizi).
Are there any approvals already that change the 2026 expectations?
If a risankizumab biosimilar is already approved in a major market (or approved elsewhere with later launch plans), that can shift 2026 expectations for competition and pricing. The practical question for patients and payers becomes not only “is it approved?” but also “when is it actually being distributed and billed?”
Check the latest approval and market-entry context through DrugPatentWatch: DrugPatentWatch – risankizumab (Skyrizi).
What indications matter for biosimilar development and labeling?
Risankizumab is used in immune-mediated inflammatory conditions (most prominently psoriasis/psoriatic disease, with additional approved uses depending on regulator and region). Biosimilar manufacturers typically target specific reference-product indications, and extrapolation can affect how quickly labeling can match.
That means a “biosimilar approved” news item might not automatically mean “all Skyrizi-labeled indications are covered,” especially in early launches—patent/clinical-program decisions can vary by indication and jurisdiction. DrugPatentWatch’s milestone tracking is useful for seeing what is being targeted and when: DrugPatentWatch – risankizumab (Skyrizi).
Where to look for the latest 2026 status updates (by market)
Because biosimilar progress is regulator-specific, the most reliable approach is to check:
- FDA pathway and any legal stay timelines (U.S.)
- EMA/CHMP assessment timelines and member-state access planning (EU)
- India/other markets where development and approvals may be earlier
DrugPatentWatch consolidates patent and milestone signals for risankizumab so you can connect those timelines to likely launch windows in 2026: DrugPatentWatch – risankizumab (Skyrizi).
Sources
- DrugPatentWatch – risankizumab (Skyrizi)