Biosimilars for Skyrizi: Availability and What to Know

There are no FDA-approved biosimilars for Skyrizi in the United States as of August 10, 2026. The FDA list contains no risankizumab product referencing Skyrizi. Other interleukin-23 medicines may appear beside Skyrizi in treatment discussions or insurer policies. They are separate active ingredients and separate therapies. The exact product name is therefore essential when evaluating a proposed coverage change.

Are biosimilars for Skyrizi available?

The FDA Purple Book record identifies Skyrizi as the 351(a) reference product, risankizumab-rzaa as its proper name, and AbbVie as its applicant. It lists multiple Skyrizi strengths and subcutaneous presentations. A future Skyrizi biosimilar would appear under a separate 351(k) application with a distinct risankizumab suffix and an explicit reference-product relationship.

Skyrizi has no conventional generic version. The FDA patient explanation distinguishes complex biologics made from living sources from the smaller chemical medicines copied as generics. FDA evaluates a follow-on biological product for high similarity and clinically meaningful differences before licensing it as a biosimilar. A development announcement, patent story, or overseas product cannot establish U.S. biosimilar status.

What Skyrizi is in IBD treatment

Skyrizi is risankizumab-rzaa, an interleukin-23 antagonist. The June 2026 FDA label includes adults with moderately to severely active Crohn's disease and ulcerative colitis. The label uses intravenous induction and subcutaneous maintenance for IBD and describes several maintenance presentations, including prefilled syringes and cartridges used with an on-body injector.

The SEQUENCE trial compared risankizumab with ustekinumab in adults with moderate-to-severe Crohn's disease after an inadequate response or unacceptable effects with tumor necrosis factor therapy. That was a comparison between different active drugs. It did not evaluate a Skyrizi biosimilar. Clinical evidence for the reference product cannot by itself grant biosimilar status to another medicine because FDA requires a dedicated comparative application.

Similar IBD drugs are not Skyrizi biosimilars

Several IBD medicines act on interleukin pathways, and their names can appear together in formulary documents. Each has its own active ingredient, application, label, dosing schedule, and reference-product identity. A plan that prefers another interleukin-23 therapy is requesting a change in treatment, even if the medicines share a broad class. A Skyrizi biosimilar would keep risankizumab as the core name and identify Skyrizi as its reference product in FDA records.

The induction-to-maintenance transition can also look like a product switch. Receiving an intravenous dose and later using a prefilled syringe or on-body injector follows the branded regimen documented in the Skyrizi label. Check the full name, suffix, strength, route, and device on each order. Those details show whether the change concerns a presentation, an active ingredient, or eventually an approved biosimilar.

Insurance implications without a Skyrizi biosimilar

An insurer cannot currently substitute an FDA-approved risankizumab biosimilar because none exists. It can still require prior authorization, a preferred specialty pharmacy, site-of-care review, or use of another covered therapy. The Crohn's & Colitis Foundation guide recommends confirming the exact product, effective date, supply source, out-of-pocket cost, and appeal process when a plan announces a medication change.

The intravenous induction phase may involve the medical benefit, while maintenance shipments may involve the pharmacy benefit. CMS publishes Part B drug-payment information for clinician-administered biological products, and commercial plan design varies. Ask for written confirmation covering both phases, including the authorized facility, specialty pharmacy, dose, approval dates, deductible, copay, and coinsurance.

How to verify a future Skyrizi biosimilar

Check the live FDA-approved biosimilar list and the Purple Book Skyrizi record. A true U.S. approval should name a proprietary product, a risankizumab suffix, an applicant, an approval date, and Skyrizi as the reference product. Interchangeability, presentations, marketing status, and actual pharmacy availability are separate facts that require their own confirmation.

As of August 10, 2026, the search answer for biosimilars for Skyrizi is zero. Patients can still face route changes, device changes, insurer-preferred alternatives, or a new specialty pharmacy. Reading the exact active ingredient and FDA license relationship keeps those events distinct and helps the gastroenterology team respond appropriately.

When a coverage notice arrives, compare it with the latest prescription before contacting the plan. Ask whether the request changes risankizumab itself, the maintenance strength, the device, the dispensing pharmacy, or the prior authorization. Save the notice, the insurer's case number, the office's submission date, and the next dose date together. That record helps distinguish a medication decision from a claim-processing or supply problem.

If the insurer names another active ingredient, request the clinical criteria and appeal instructions in writing. The prescribing team can then evaluate the proposed therapy and submit supporting records within the plan's deadline. If the notice claims to name a Skyrizi biosimilar, verify the proprietary name and suffix in FDA's list before treating the statement as current.