Fresenius Kabi and Formycon have secured the US Food and Drug Administration (FDA) approval for Otulfi (ustekinumab-aauz), their biosimilar to Johnson & Johnson’s (J&J’s) Stelara.
Stelara is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23, for the treatment of immune-mediated disorders.
Otulfi is indicated for the same conditions as Stelara, including Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.
It is approved for both subcutaneous and intravenous formulations and is contraindicated in patients with significant hypersensitivity to ustekinumab or any of its excipients.
The FDA approval of Otulfi is supported by a stringent evaluation of a comprehensive data package including analytical, pre-clinical, clinical, and manufacturing data.
According to the data, Otulfi’s efficacy, safety, pharmacokinetics, and immunogenicity were comparable to the reference drug Stelara in patients with moderate to severe plaque psoriasis.
Fresenius Kabi biopharma president and management board member 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.”
Otulfi is Fresenius Kabi’s fourth biosimilar authorised in the US, following its biosimilars Idacio (adalimumab-aacf), Tyenne (tocilizumab-aazg) and Stimufend (pegfilgrastim-fpgk).
The drug was originally developed by Formycon, a Germany-based independent drugmaker developing biosimilar drugs and formulations.
In February last year, Fresenius Kabi and Formycon entered a partnership for the commercialisation of Otulfi across global markets.
In March this year, the two partners reached a settlement agreement with J&J for the commercialisation of their ustekinumab biosimilar in Europe and Canada.
Recently, the European Commission (EC) approved Otulfi for both subcutaneous and intravenous formulations, for the same indications as Stelara.
Formycon CEO Stefan Glombitza said: “After FYB203 end of June, this marks our second FDA approval this year and we are very proud of achieving this milestone in line with our plans.
“Our ustekinumab biosimilar FYB202 exemplifies Formycon´s technical expertise and capabilities in developing high-quality, safe and affordable biologics.
“Particularly in the area of chronic inflammatory diseases, only a limited number of patients worldwide have access to biologic therapies or often have to wait for years to receive this highly effective treatment.”
