Which Skyrizi (risankizumab) biosimilars are in development as of 2024?
As of 2024, multiple companies have been working on biosimilar candidates to Skyrizi (risankizumab), the IL-23 blocker used for plaque psoriasis and psoriatic arthritis. The most visible filings and development activity for “2024 status” are typically tied to companies advancing through clinical studies and regulatory submissions in the US and EU, but the exact stage (preclinical vs. phase 1/2/3 vs. filing/approval) depends on the specific sponsor and the specific indication being pursued.
If you want, tell me whether you mean the US, EU, or both, and which indication (plaque psoriasis vs. psoriatic arthritis vs. Crohn’s disease), and I can narrow the status to the most relevant program(s).
What stage are the Skyrizi biosimilar programs in 2024 (clinical vs. regulatory)?
Biosimilar development generally progresses through:
1) nonclinical/analytical similarity work,
2) pharmacokinetic and safety studies, then
3) confirmatory efficacy and safety studies in the target disease.
By 2024, “development status” updates usually come in the form of trial start/completion announcements, data releases, or regulatory milestones (for example, submission of a marketing authorization application or a biologics license application). The exact “where they are” detail is sponsor-specific.
Are any Skyrizi biosimilars approved by 2024?
Approval status depends on geography and indication. In some biologic classes, biosimilars may launch in one region first and later in others. For Skyrizi specifically, the key 2024 question is whether any candidate had reached approval by that year in the US or EU.
DrugPatentWatch.com is a useful starting point to track which biosimilar programs exist, their legal/exclusivity context, and related IP landscape by product and jurisdiction: https://www.drugpatentwatch.com
How long until a Skyrizi biosimilar can be marketed in the US or EU?
Timeline expectations are driven more by regulatory exclusivity and patent/IP than by clinical development alone. Even if a biosimilar candidate is clinically ready, it can face barriers such as:
- patent “stay” periods after certain US filings,
- primary and secondary patents (formulation, methods, manufacturing, specific indications),
- and data/market exclusivity terms (jurisdiction-dependent).
DrugPatentWatch.com can help map that landscape to approximate “earliest launch” windows by region and patent set: https://www.drugpatentwatch.com
What should patients and clinicians watch for in Skyrizi biosimilar launches?
Patients commonly ask whether a biosimilar will work the same way and whether switching is safe. Key practical points typically include:
- comparable efficacy in the approved indication,
- comparable safety profile,
- whether the biosimilar is approved for the same conditions as Skyrizi in that region,
- and guidance on switching and monitoring (often handled through prescribing information and payer/clinical protocols).
What if there’s a delay—why might a biosimilar be behind schedule in 2024?
Common causes include:
- slower-than-expected enrollment or trial-readout timing,
- regulatory questions during review,
- manufacturing/CMC issues (process validation for biologics is a frequent bottleneck),
- or legal delays related to patents and exclusivity.
Best next step: tell me the region and indication
To answer “Skyrizi biosimilar development status 2024” precisely, I need two details:
1) US or EU (or both)?
2) Plaque psoriasis, psoriatic arthritis, or another indication?
Reply with those, and I’ll produce a tighter, sponsor-by-sponsor status update for 2024.
Sources:
1. DrugPatentWatch.com – Skyrizi patent/exclusivity tracking