On 15 February 2021, South Korea-based biotechnology company Celltrion Healthcare (Celltrion) announced that its adalimumab biosimilar, Yuflyma (CT P17), had received European Commission (EC) approval.
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 (AS), Crohn’s disease, psoriasis and ulcerative colitis.
The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 11 December 2020 [1]. The EC’s approval is based on analytical, preclinical and clinical studies, which, according to Celltrion, demonstrate that Yuflyma is comparable to the reference product, in terms of safety, efficacy, pharmacokinetics, pharmacodynamics and immunogenicity up to 24 weeks and one year following treatment.
Celltrion says that this is ‘the first adalimumab biosimilar with a high concentration, low-volume and citrate-free formulation’. According to IQVIA, 60% of the adalimumab market is captured by the high concentration formulation in Europe and over 90% of the original adalimumab market has already been replaced with a high concentration version.
The high concentration formulation of Yuflyma has been approved for all intended indications for the treatment of multiple chronic inflammatory diseases including chronic inflammatory diseases; rheumatoid arthritis, juvenile idiopathic arthritis, AS, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, uveitis and paediatric uveitis.
Yuflyma marks the 10th European approval for an adalimumab biosimilar [2]. However, despite the significant competition from other biosimilars, Celltrion believes that it is distinguishing itself from the crowd by the development of a high concentration biosimilar, which it says will ‘provide a significant alternative to the adalimumab treatment category’. The company has also looked to ensure improved convenience for patients, as well as providers, by providing a 29G needle size, latex-free device to reduce allergy risk. In addition, Yuflyma has a long storage period of up to 30 days at room temperature.
The EC approval is valid in all EU Member States as well as in the European Economic Area (EEC) countries Iceland, Liechtenstein and Norway. Celltrion says that it will take the EC Decision Reliance Procedure (ECDRP) to gain approval to launch in the UK.
Celltrion also announced on 17 February 2021 that it had launched the subcutaneous version of its infliximab biosimilar, Remsima SC, in France. The company first launched Remsima SC in Europe (Germany and the UK) back in February 2020 [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of adalimumab biosimilar Yuflyma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-adalimumab-biosimilar-Yuflyma
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Celltrion launches infliximab biosimilar Remsima SC in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 19]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-launches-infliximab-biosimilar-Remsima-SC-in-Europe
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