FDA BLA updates from Celltrion and Accord

In January 2024, Celltrion submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product Actemra ( tocilizumab). In addition, Accord BioPharma, announced that the FDA accepted its BLA for DMB-311, a biosimilar to Stelara (ustekinumab), approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Celltrion’s tocilizumab
Tocilizumab is a humanized monoclonal antibody which acts against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children [1].

Celltrion’s BLA is based on data from their global phase III clinical trial designed to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P47 compared to the reference product Actemera. This was carried out in patients with moderate to severe active rheumatoid arthritis with inadequate response to methotrexate up to Week 52.

Accord’s ustekinumab biosimilar
Ustekinumab is a humanized monoclonal antibody that interferes with the triggering of the body’s inflammatory response through the suppression of certain cytokines. Specifically, it blocks interleukin IL 12 and IL 23 which help activate certain T cells. It binds to the p 40 subunit of both IL 12 and IL 23 so that they subsequently cannot bind to their receptors. It is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis [2].

Stelara is one of the best-selling biologicals in the US, with US sales reaching US$6.4 billion in 2022, according to Johnson & Johnson's (J&J) annual report. Globally, Stelara stood at recorded drug sales of US$9.723 billion in the same year.

Patents for Stelara in the US expired in September 2023 [3]. However, there were a number of lawsuits between Stelara manufacturer, Janssen Biotech Inc, a J&J company, and biosimilars producers, which have led to delays in the launch of ustekinumab biosimilars in the US [4, 5]. In one such lawsuit, Accord reached a settlement that will allow it to launch its DMB-311 ustekinumab biosimilar no later than 15 May 2025, following its FDA approval.

The joint development for DMB-3115 began in 2013 by Dong-A Socio Holdings and Meiji Seika Pharma. Exclusive commercialization rights were granted to Intas Pharmaceuticals, and as global subsidiary of Intas Pharmaceuticals, Accord BioPharma is responsible for commercialization in the US.

The BLA submission for DMB-3115 is based on results from phase III multi-regional clinical trials in patients with plaque psoriasis. The results demonstrated that DMB-3115 and its reference product, Stelara, are highly similar, and have no clinically meaningful differences in terms of quality, safety and efficacy.

There are a number of other ustekinumab biosimilars in the pipeline. These are being developed by companies such as Celltrion [6] and Fomycon [7].

Amgen announces positive phase III results for ustekinumab biosimilar

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

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FORO LATINOAMERICANO
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 29]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of ustekinumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 29]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-ustekinumab
3. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
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 Feb 29]. Available from: www.gabionline.net/pharma-news/j-j-lawsuits-settled-over-ustekinumab-biosimilars
5. 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 Feb 29]. Available from: www.gabionline.net/pharma-news/fresenius-kabi-and-formycon-reach-agreement-with-j-j-alvotech-and-teva-expand-partnership
6. GaBI Online - Generics and Biosimilars Initiative. Korean biosimilars makers pipelines and expansion [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 29]. Available from: www.gabionline.net/Pharma-News/Korean-biosimilars-makers-pipelines-and-expansion
7. GaBI Online - Generics and Biosimilars Initiative. Phase I trials started for aflibercept and ustekinumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 29]. Available from: www.gabionline.net/Biosimilars/News/Phase-I-trials-started-for-aflibercept-and-ustekinumab-biosimilars

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