Insight into the FDA Approval of Ustekinumab Biosimilar

On Oct. 31, the U.S. Food & Drug Administration (FDA) approved Wezlana (ustekinumab-auub) to treat patients with psoriasis, psoriatic arthritis (PsA) and other conditions. Ustekinumab-auub is biosimilar to and interchangeable with its reference product, Stelara (ustekinumab). This agent was approved for the same indications as its reference product.¹

Background: Ustekinumab is a human interleukin (IL) 12 and IL-23 antagonist, anti-inflammatory agent given by subcutaneous injection or intravenous infusion at least every four weeks. It was first FDA approved in September 2009.² At that time, it was indicated for adults with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy. Through March 2023, ustekinumab was subsequently approved to treat:³

• Adult patients with active PsA, moderate to severe active Crohn’s disease and/or moderate to severe active ulcerative colitis; and
• Pediatric patients 6 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and/or those with active PsA.

Biosimilar Data

The approval of ustekinumab-auub was based on a comprehensive scientific evidence review that demonstrated that the agent is highly similar to ustekinumab, with no clinically meaningful differences between the products related to safety, purity and potency. The review analyzed data from an extensive battery of chemical and biological tests and biological assays that confirmed the similarity of ustekinumab-auub and ustekinumab in structural and functional features, including those known to affect safety and efficacy. Comparisons between the agents were also made for human pharmacokinetic data, clinical immunogenicity data and other clinical safety and effectiveness data.

Like with ustekinumab, the most common side effect of ustekinumab-auub is infection. Other adverse effects include nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting and injection site erythema. Also like its reference product, ustekinumab-auub will be dispensed with a medication guide due to the increased risk of serious infections, malignancies, hypersensitivity reactions and cases of posterior reversible encephalopathy syndrome that occurred during clinical trials.

It’s expected that ustekinumab-auub will become available in the U.S. no later than Jan. 1, 2025. Amgen, the maker of ustekinumab-auub, has agreed to a later launch in exchange for Johnson & Johnson, the maker of ustekinumab, dropping a patent infringement lawsuit.⁴

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. FDA approves interchangeable biosimilar for multiple inflammatory diseases [news release]. U.S. Food & Drug Administration. 2023 Oct 31.
2. Biologics license application: Approval letter Stelara (ustekinumab). U.S. Food & Drug Administration. 2009 Sep 25.
3. Highlights of prescribing information: Stelara (ustekinumab). 2023 Mar.
4. Phengsitthy N. Amgen’s Wezlana adds legal obstacles to drug pricing battle. Bloomberg Law. 2023 Nov 9.