FDA approves third ustekinumab biosimilar Pyzchiva

On 28 June 2024, the US Food and Drug Administration (FDA) approved a third ustekinumab biosimilar, Pyzchiva (ustekinumab-ttwe). This product has been developed by Samsung Bioepis and is commercialised by Sandoz. It is a biosimilar of reference product Johnson & Johnson’s (J&J) Stelera.

Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines; it is a human interleukin (IL)–12 and IL-23 antagonist [1].

FDA has approved biosimilar Pyzchiva (ustekinumab-ttwe) in the following formulations: 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection, and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion. Pyzchiva is approved for all indications of its reference medicine, including Crohn's disease, plaque psoriasis, psoriatic arthritis, and ulcerative colitis.

Additionally, FDA granted provisional determination for interchangeability designation for Pyzchiva, as it is currently subject to an unexpired period of exclusivity for the first interchangeable ustekinumab biosimilar, Amgen’s Wezlana (ustekinumab-auub) [2].

The FDA’s approval of Pyzchiva is based on a totality of evidence including analytical, non-clinical and clinical data demonstrating biosimilarity to Stelara, with no clinically meaningful differences in terms of safety, purity and potency. The randomized, double-blind, three-arm, parallel-group, single-dose phase I clinical study (NCT04772274) demonstrated pharmacokinetic (PK) equivalence and comparable safety, tolerability, immunogenicity profiles between Pyzchiva and the reference, Stelara in healthy volunteers. The randomized, double-blind, multicentre phase III clinical study (NCT04967508), conducted in patients with moderate to severe plaque psoriasis, demonstrated biosimilarity of Pyzchiva with the reference through equivalent efficacy and comparable safety and PK profiles up to Week 28. In addition, the phase III study demonstrated biosimilarity of SB17 to Stelara up to Week 28 in terms of efficacy, safety, PK, and immunogenicity.

Sandoz holds the rights to commercialize Pyzchiva in the US, Canada, the European Economic Area (EEA), Switzerland, and the UK. Meanwhile, Samsung Bioepis is responsible for its development, registration, intellectual property, manufacturing, and supply.

Pyzchiva already received EC approval on 22 April 2024 [3]. The product should become available in the US after February 2025, in accordance with the settlement and license agreements made between J&J/Janssen Biotech [4].

The other two ustekinumab biosimilars approved are:

Alvotech’s Selarsdi (ustekinumab-aekn), approved on 16 Apr 2024 [5] and
Amgen’s Wezlana (ustekinumab-auub), approved as the first interchangeable ustekinumab on 31 Oct 2023 [6].

Amgen announces positive phase III results for ustekinumab biosimilar

Phase I trials started for aflibercept and ustekinumab biosimilars

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 16]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 16]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
3. GaBI Online - Generics and Biosimilars Initiative. EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 16]. Available from: www.gabionline.net/biosimilars/news/ec-biosimilar-approvals-omlyclo-jubbonti-wyost-and-pyzchiva
4. GaBI Online - Generics and Biosimilars Initiative. J&J lawsuits settled over ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 16]. Available from: www.gabionline.net/pharma-news/j-j-lawsuits-settled-over-ustekinumab-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 16]. Available from: www.gabionline.net/biosimilars/news/fda-approves-ustekinumab-trastuzumab-and-tocilizumab-biosimilars
6. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Jul 16]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana

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