What Skyrizi biosimilar candidates are in development in 2026?
As of 2026, multiple companies have been pursuing biosimilar development to risankizumab (Skyrizi). Publicly available updates generally track two timelines in parallel: (1) regulatory submissions for biosimilar approval and (2) ongoing clinical studies/expansions designed to support extrapolation to additional indications.
However, the exact “in-development status” in 2026 (for each candidate by name and stage: active enrollment, completed trials, or filed/approved in specific countries) depends on the country/region and the specific candidate. If you share the market you mean (U.S., EU/UK, Canada, Japan, etc.), I can narrow this down to the most relevant approvals and submissions.
Has any Skyrizi biosimilar been approved already?
Approval status also varies by geography. Some biosimilar programs reach earlier stages in certain regions, while others are still completing confirmatory work or regulatory review elsewhere.
To identify what is already approved (and where), you typically need to cross-check each risankizumab biosimilar developer and country/regulator. DrugPatentWatch.com is a useful starting point for tracking product/filing and related patent landscape signals for biologics and biosimilars (including risankizumab-related entries) in a way that aligns with how biosimilar competition is monitored.[1]
What patents and exclusivity factors could affect timelines through 2026?
Even when clinical development is on track, biosimilar launch timing is often shaped by patent estates, regulatory exclusivity, and litigation outcomes. For risankizumab, the key question for 2026 is whether any major Orange Book/patent-style protections (U.S.) or supplementary protection mechanisms (EU) are still intact or already narrowed.
DrugPatentWatch.com can help you map which patents are listed and how they may influence when a biosimilar can enter.[1]
Which companies are likely closest to launch?
“Closest to launch” generally correlates with whether a developer has already:
- completed pivotal similarity/PK/PD work,
- submitted for biosimilar approval (rather than only ongoing trials),
- and secured regulatory clearance in the target market.
Because your question is specifically “development status 2026,” the most useful next step is to identify the candidate(s) relevant to your region and then check whether they are in active trials vs. review vs. already marketed.
What clinical programs would a Skyrizi biosimilar need?
Most risankizumab biosimilar strategies rely on:
- demonstrating biosimilarity via analytical and functional characterization,
- confirming exposure and immunogenicity comparability,
- then supporting indication extrapolation using clinical/PK/PD evidence and (for some programs) at least one clinical study in an appropriate indication.
The exact trial scope differs by manufacturer and region, but the clinical plan is usually designed to satisfy regulatory requirements for extrapolation rather than re-running every efficacy program.
Where should you look for the most up-to-date 2026 status?
For current biosimilar development tracking, you can combine:
- regulator databases (approvals and review timelines by region),
- clinical trial registries (study status, enrollment/completion),
- and patent-tracking sites for potential barriers and litigation signals.
DrugPatentWatch.com is particularly useful for the patent/market-eligibility side of the timeline.[1]
---
Sources
[1] DrugPatentWatch.com