Otulfi (ustekinumab-aauz)/FYB202
On 27 September 2024, the FDA approved Fresenius Kabi/Formycon’s FYB202/Otulfi (ustekinumab-aauz) in both subcutaneous and intravenous formulations for the treatment of adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Otulfi (ustekinumab-aauz) is available as 45 mg and 90 mg for injection. 

The approval of Otulfi (ustekinumab-aauz) was based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. Otulfi demonstrated comparable efficacy, safety and pharmacokinetics to the reference drug Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).

In accordance with the patent settlement between Fresenius Kabi, Formycon and Johnson & Johnson, Fresenius Kabi has the right to market Otulfi in the US no later than 22 February 2025 [1].

FYB202/Otulfi (ustekinumab-aauz) was developed by Formycon, with Fresenius Kabi as their commercialization partner in Europe and the US.

Otulfi has also been approved by the European Commission on 12 September 2024 [2].

Epysqli (eculizumab-aagh)
On 22 July 2024, the FDA approved Samsung Bioepis’ Epysqli (eculizumab-aagh) for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. EPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). 

Epysqli (eculizumab-aagh) is available as a 300 mg/30 mL (10 mg/mL) solution for intravenous use.

The approval of Epysqli (eculizumab-aagh) was based on on a totality of evidence including analytical, non-clinical and clinical data demonstrating it is highly similar to Soliris, with no clinically meaningful differences between Epysqli and Soliris in terms of safety, purity and potency: The randomized Phase I, double-blind, three-arm, parallel group, single-dose study in healthy volunteers (NCT03722329) demonstrated pharmacokinetics (PK) equivalence and comparable pharmacodynamic (PD), safety, tolerability, and immunogenicity profiles between Epysqli and Soliris. Additionally, the randomized Phase 3, double-blind, multicenter, cross-over study in PNH patients (NCT04058158) demonstrated clinical equivalence in efficacy, safety, PK, and immunogenicity between Epysqli and Soliris. 

Epysqli has also been approved by the European Commission on 26 May 2023 [3] and Korea’s Ministry of Food and Drug Safety.

The FDA approves the first eculizumab biosimilar Bkemv on 28 May 2024, for the same indications as the originator and as an interchangeable biosimilar [4].

Related articles
Positive phase III results for Samsung Bioepis’ Soliris biosimilar

Alexion delays Soliris biosimilar until 2025

References
1. GaBI Online - Generics and Biosimilars Initiative. Fresenius Kabi and Formycon reach agreement with J&J, Alvotech and Teva expand partnership [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 29]. Available from: www.gabionline.net/pharma-news/fresenius-kabi-and-formycon-reach-agreement-with-j-j-alvotech-and-teva-expand-partnership
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 29]. Available from: www.gabionline.net/biosimilars/news/ec-approval-for-three-ustekinumab-biosimilar-eksunbi-fymskina-otulfi
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of eculizumab biosimilar Epysqli [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 29]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-eculizumab-biosimilar-epysqli
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves first eculizumab biosimilar Bkemv for two rare diseases [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 29]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-eculizumab-biosimilar-bkemv-for-two-rare-diseases

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