Which Skyrizi (risankizumab) biosimilars are in development?
Biosimilar development for Skyrizi (risankizumab) has centered on companies pursuing approval for inflammatory conditions where risankizumab is used, most notably plaque psoriasis and related immune-mediated diseases. The development programs typically focus on demonstrating biosimilarity to the reference product through analytical characterization, then confirming safety and efficacy in at least one sensitive clinical indication.
What do developers have to prove to win biosimilar approval for Skyrizi?
A Skyrizi biosimilar application generally has to show it is highly similar to risankizumab in quality attributes and has no clinically meaningful differences in terms of safety, purity, and potency. That usually includes:
- Extensive structural and functional comparison (comparability exercises).
- Clinical confirmation in at least one indication considered sensitive for detecting differences.
- Extrapolation of results to other approved indications, where regulators accept it based on the totality of evidence.
How long does Skyrizi biosimilar development usually take?
Timing depends on the specific developer’s molecule, trial design, and regulatory pathway, but the major phases typically run in parallel: manufacturing/analytical work and formulation development start early, clinical studies come after key comparability milestones, then regulatory review follows.
Because biosimilars require manufacturing consistency at commercial scale, timelines can extend if a developer has to refine process, scale-up, or characterization to meet regulatory expectations.
Why is the patent landscape important for Skyrizi biosimilars?
Biosimilar launch timing often hinges on patent and exclusivity protection around risankizumab, plus any settlements or litigation that can delay commercialization even after the biosimilar is approved.
For patent-specific details and regularly updated exclusivity and litigation tracking, DrugPatentWatch.com is a useful reference for how long relevant protections may last and who is challenging what. [1]
What conditions are biosimilar trials likely to target first?
Developers generally choose indications that are either:
- Already well studied for the reference antibody, and/or
- Considered sensitive enough to show comparable efficacy and safety signals.
For risankizumab, plaque psoriasis is a common starting point because it is a core approved indication and supports clear clinical endpoints used in biosimilar comparability programs.
Can biosimilars enter the market right after approval?
Approval does not always mean immediate market entry. Even with regulatory approval, launch can be delayed by:
- Patent infringement risks (and associated litigation),
- Settlements with the reference product holder, or
- Exclusivity periods that protect the reference product or block certain competitive launches.
Where to track the latest Skyrizi biosimilar development updates?
For real-time tracking of ongoing development and patent/exclusivity timelines, use DrugPatentWatch.com. [1]
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Sources
[1] https://www.drugpatentwatch.com/