FDA approves Zymfentra and advances for Yuflyma in the US

Biosimilares/Novedades | Posted 05/12/2023 post-comment0 Post your comment

On 23 October 2023, the US Food and Drug Administration (FDA) approved Celltrion’s Zymfentra (infliximab-dyyb) biosimilar as the first subcutaneous (SC) formulation of infliximab. In addition, Celltrion USA signed a contract with Ventegra to add Yuflyma (adalimumab-aaty) as a preferred formulary product in both public and private insurance markets.

Pharmacokinetics 1 V13K15

Zymfentra
Zymfentra  is a subcutaneous formulation of the biosimilar Inflectra (infliximab-dyyb).

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. The originator drug is Johnson & Johnson and Merck’s blockbuster Remicade [1]. 

Zymfentra is supplied as a single-dose pre-filled syringe, a pre-filled syringe with needle shield, or a pre-filled pen, all containing 120mg/mL solution. All patients must complete an IV induction regimen with an infliximab product before starting Zymfentra.

The product is designed as a maintenance therapy for patients with moderately to severely active ulcerative colitis and Crohn’s disease. For maintenance treatment, patients may self-inject Zymfentra after receiving proper training in SC injection technique from their healthcare provider.

Other infliximab biosimilars approved in the US include [2]:

  • infliximab-axxq (Avsola) – given by IV infusion
  • infliximab-dyyb (Inflectra [IV infusion]; Zymfentra [SC injection])
  • infliximab-abda (Renflexis) – given by IV infusion

Yuflyma
Ventegra is a major US Medical Benefits Manager that administers pharmacy benefits through its Pharmacy Services Administration (PSA) model. Under the terms of their agreement with Celltrion, Ventegra will now incorporate Yuflyma (adalimumab-aaty) as a preferred drug in its formulary. As a result, Celltrion has secured access in the appropriate channel for approximately 3.6% of the entire US population.  

Yuflyma was approved in the US in June 2023 and is a high-concentration and citrate-free formulation of Humira (adalimumab) biosimilar. FDA granted its approval for the treatment of eight conditions: rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa [3]. 

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis [4].

Related articles
New data on infliximab and adalimumab biosimilars at EULAR 2022 (gabionline.net)

Celltrion to build facility in China and increase new drug output

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Dec 5]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-infliximab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Dec 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. Celltrion: advances for Yuflyma and Vegzelma biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Dec 5]. Available from: www.gabionline.net/biosimilars/news/celltrion-advances-for-yuflyma-and-vegzelma-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Dec 5]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab

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