Fresenius Kabi now has four FDA-approved biosimilars. Image credit: Shutterstock/ JHVEPhoto.

Fresenius Kabi and Formycon have won US Food and Drug Administration (FDA) approval for Otulfi (ustekinumab-aauz), a biosimilar that references Johnson & Johnson’s (J&J) blockbuster inflammatory drug Stelara (ustekinumab).

As with Stelara, Otulfi is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis, as per a 30 September press release.

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The FDA based its decision on data that showed comparable efficacy, safety, pharmacokinetics and immunogenicity to J&J’s drug in patients with moderate to severe psoriasis vulgaris, according to Fresenius Kabi and its commercial partner Formycon.

The news comes days after the European Commission approved Otulfi in the same indications apart from ulcerative colitis. The FDA nod for the drug from Fresenius Kabi – part of the German healthcare company Fresenius – marks the fourth Stelara biosimilar approval in the US.

Amgen’s Wezlana (ustekinumab-auub) won the race for the first Stelara biosimilar in the country in November 2023. Alvotech and Teva’s Selarsdi (ustekinumab-aekn) was then approved in April this year, whilst Samsung Bioepis and Sandoz’s Pyzchiva (ustekinumab-ttwe) followed suit three months later.

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Stelara is a monoclonal antibody that works by blocking the activity of the cytokines interleukin-12 and interleukin-23, which play an important role in inflammatory and immune responses. The drug generated $10.9bn in sales in 2023 for J&J, making it the top-selling product in the company’s portfolio.

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J&J has fought hard to sustain revenue streams for its prized possession, initiating lawsuits against biosimilar developers two years ago. The lawsuits, which have since been settled, mean biosimilar makers – including Fresenius Kabi and Formycon – can only launch their products in 2025. Amgen’s Wezlana will be allowed to roll out in January next year, while Otulfi will launch a month later, according to Fresenius Kabi.

The introduction of biosimilars into the market will significantly weaken Stelara’s sales, with revenue expected to drop to $1.2bn by 2030, according to analysis by GlobalData.

GlobalData is the parent company of Pharmaceutical Technology.

Otulfi represents the fourth US biosimilar approval for Fresenius Kabi, with the company having already marketed its own versions of AbbVie’s Humira (adalimumab), Genentech’s Actemra (tocilizumab) and Amgen’s Neulasta (pegfilgrastim). 

Fresenius Kabi’s president [of] biopharma Dr. Sang-Jin Pak said: “[Otulfi’s approval] is an important milestone on our pathway to consistently broadening our biopharma portfolio in the US and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally.”