With the latest development, Otulfi is now intended to treat Crohn’s disease, moderate to severe plaque psoriasis, ulcerative colitis and active psoriatic arthritis.
Fresenius Kabi and Formycon signed an international commercialisation deal in February last year for the ustekinumab biosimilar candidate for various markets across the globe.
A human monoclonal antibody, ustekinumab acts on the interleukin-12 and interleukin-23 cytokines which hold a key role in inflammatory and immune responses.
The latest FDA approval for Otulfi is based on a detailed assessment of the comprehensive data package which comprised pre-clinical, analytical, clinical and manufacturing findings.
The company noted that Otulfi showed efficacy, safety, pharmacokinetics and immunogenicity in line with Stelara in people with moderate to severe psoriasis vulgaris (plaque psoriasis).
As per the latest approval, Otulfi is intended for use as subcutaneous and intravenous formulations to provide an alternative treatment option for patients treated with ustekinumab in the US.
Otulfi is not indicated for use in people with hypersensitivity to ustekinumab or any of the excipients.
Otulfi is said to be the fourth biosimilar of Fresenius Kabi to receive marketing authorisation in the US.
Earlier, the company received approvals for biosimilars Idacio (adalimumab-aacf), Tyenne (tocilizumab-aazg) and Stimufend (pegfilgrastim-fpgk), which are now commercially available.
The autoimmune and oncology biosimilar pipeline of Fresenius Kabi currently has various molecules in the initial and late development stages.
Fresenius Kabi Biopharma president and management board member Dr Sang-Jin Pak said: “The FDA approval of Otulfi, Fresenius Kabi’s fourth biosimilar product in the US market, 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.”