In March 2023, the US Food and Drug Administration (FDA) approved Sandoz’s Hyrimoz biosimilar, a citrate-free high-concentration formulation (HCF) of adalimumab, as well as Coherus Biosciences’ (Coherus) innovative single-dose, prefilled autoinjector presentation of Udenyca (pegfilgrastim-cbqv).
Hyrimoz biosimilar adalimumab gains US and EC approval
Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis [1].
The reference product is AbbVie’s Humira. FDA accepted Sandoz’s application for the HCF of Hyrimoz on 21 July 2022 [2].
This 23 March 2023 announcement for the approval of the HCF of Hyrimoz in the US follows Sandoz’s January 2023 announcement that the European Medicines Agency’s Committee for Medicinal Products for Human Use had adopted a positive opinion for the marketing authorization of their HCF of Hyrimoz biosimilar adalimumab [3]. Later on 3 April 2023, the European Commission (EC) granted marketing authorization in the European Union for the citrate-free HCF (100 mg/mL) of biosimilar Hyrimoz.
The US authorization includes seven indications covered by the reference medicine Humira: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.
The EC authorization includes all indications of the reference medicine Humira: rheumatic diseases, Crohn's disease, ulcerative colitis, plaque psoriasis, uveitis and hidradenitis suppurativa.
Hyrimoz will be available in the US from July 2023 as a 100 mg/mL formulation.
Udenyca autoinjector biosimilar pegfilgrastim gains US approval
Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy [4].
Coherus’ pegfilgrastim biosimilar, Udenyca, gained FDA approval in November 2018.
The introduction of the Udenyca autoinjector as a streamlined, easy-to-use design for use in both in-office and at-home settings of care, has huge potential to increase accessibility of treatment to patients.
A number of biosimilars of the originator product, Amgen’s Neulasta, have been approved and are available globally. Udenyca itself has been approved in both the US and Europe [5, 6]. However, ‘The Udenyca autoinjector represents the first innovation in the pegfilgrastim space in eight years and highlights Coherus’ commitment to developing innovative solutions that expand access and address the needs of patients undergoing cancer treatment,’ said Denny Lanfear, CEO of Coherus.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 14]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
2. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for high concentration adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 14]. Available from: www.gabionline.net/biosimilars/news/fda-accepts-application-for-high-concentration-adalimumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Advances for adalimumab biosimilars in Saudi Arabia, Europe and Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 14]. Available from: www.gabionline.net/biosimilars/news/advances-for-adalimumab-biosimilars-in-saudi-arabia-europe-and-canada
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 14]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-of-pegfilgrastim
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 14]. Available from:
www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 14]. Available from:
www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
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