Stelara Biosimilar OK’d With Interchangeability

A biosimilar version of the multipurpose biologic drug ustekinumab has been approved by the FDA and can be swapped interchangeably with the original product sold as Stelara.

The new version carries the brand name Wezlana and the generic name sports the suffix -auub, the FDA said in announcing the approval late Tuesday. Amgen is the manufacturer.

Indications for Wezlana in adults are the same as for Stelara:

• Moderate to severe plaque psoriasis, for patients who otherwise could receive phototherapy or systemic therapy
• Active psoriatic arthritis
• Moderate to severe Crohn’s disease
• Moderate to severe ulcerative colitis

Like Stelara, the new version is also approved for children ages 6 and older with plaque psoriasis or psoriatic arthritis. Neither product has yet been okayed for pediatric bowel disorders.

Wezlana’s label will also contain all the same cautions and warnings as Stelara’s, such as heightened infection risk.

Ustekinumab is a dual inhibitor of interleukins 12 and 23. It was among the first biologic drugs that patients could self-inject.

The approval for interchangeability is a coup for Amgen, as only a handful of other biologics have gained that status. It required an extra level of clinical testing to demonstrate that patients experienced no issues when switching between the two versions. With this designation, pharmacies can substitute the biosimilar for the original drug without the prescriber having to specify it.

HHS Secretary Xavier Becerra issued a statement applauding the FDA decision as promoting competition and lower drug costs. “Today’s action by the FDA is a welcome step forward to approve a biosimilar for a drug taken by tens of thousands of Americans,” he said. “Through President Biden’s Inflation Reduction Act, we were able to remove some of the incentives for drug companies to block biosimilar and generic drugs from entering the market — instead encouraging healthy competition.”

That latter boast, however, seems odd in light of an agreement reached earlier this year between Amgen and Stelara’s maker, Johnson & Johnson, that appears likely to keep Wezlana off pharmacy shelves for more than year. As typically happens with biosimilars, J&J had sued Amgen preemptively for patent infringement. In May, they settled out of court; full terms weren’t disclosed but Amgen said it could have to wait until Jan. 1, 2025, to begin selling its version.

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