FDA approves first Stelara biosimilar, Wezlana

The FDA has approved Wezlana (ustekinumab-auub), making it the first approval for blockbuster biosimilar drug Stelara (ustekinumab). The agency also granted Wezlana an interchangeability designation.

Wezlana was developed by Amgen and will be used to treat:

• Adult and pediatric patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic treatment
• Adult and pediatric patients with active psoriatic arthritis
• Adults with moderately to severely active Crohn’s disease
• Adults with moderately to severely active ulcerative colitis

Wezlana’s approval was based on data from a phase 3 trial that confirmed that the biosimilar, then named ABP 654, had comparable safety and effectiveness profiles to the reference product.

The study was a multicenter, randomized, double-blind, comparative clinical trial and met the primary efficacy endpoint, indicating that the biosimilar had no clinically meaningful differences compared to Stelara. The analysis assessed percent change in Psoriasis Area Severity Index in adult patients with moderate to severe plaque psoriasis over 12 weeks. A total of 563 patients were randomized to receive either the biosimilar (n = 281) or the reference product (n = 282).

The interchangeability designation will allow Wezlana to replace Stelara at the pharmaceutical level without the need for a pharmacist to first obtain permission from a supplier. This designation is intended to increase biosimilar access and convenience for patients, who often face long waits to obtain a drug because they must wait for provider approval.

Wezlana is the seventh biosimilar to be considered interchangeable, following Semglee (insulin glargine-yfgn), Cyltezo (adalimumab-adbm), Cimerli (ranibizumab-eqrn), Rezvoglar (insulin glargine-aglr), Byooviz (ranibizumab-runa) and Abrilada (adalimumab-afzb).

For a company to achieve interchangeability of a biosimilar, in most cases excluding insulin products and intravitreally administered products, the company must conduct a switching study, in which patients are switched between the reference product and the biosimilar several times to confirm that the switch is safe and effective. has no impact on clinical results.

Stelara is an interleukin-12 and interleukin-23 antagonist used for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The original product is available in intravenous and subcutaneous formulations.

Earlier this year, Amgen agreed with Johnson & Johnson (J&J), the parent company of Stelara’s maker (Janssen), to delay Wezlana’s planned launch date from late 2023 to no later than January 1, 2025.

According to J&J’s annual financial report, Stelara sales in the United States reached $6.4 billion in 2022. The company said it expects sales to decline after the patent expires and the the subsequent arrival of biosimilars on the market.

An estimated 125 million people suffer from psoriasis worldwide, including approximately 14 million in Europe and more than 7.5 million people in the United States. About 80% of people with psoriasis have plaque psoriasis.