EC approval for adalimumab biosimilar Cyltezo

Biosimilars/News | Posted 17/11/2017 post-comment0 Post your comment

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer) announced on 13 November 2017 that it had received European Commission (EC) approval for its biosimilar adalimumab product Cyltezo (BI 695501).

Approved V13G05

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.

The approval by the EC follows the European Medicines Agency’s Committee for Medicinal Products for Human Use positive recommendation on 15 September 2017 [1].

Cyltezo has been approved for the treatment of multiple chronic inflammatory diseases in adults, including, ankylosing spondylitis, axial spondyloarthritis, Crohn’s disease, hidradenitis suppurativa, psoriasis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, uveitis. It has also been granted marketing authorization for the treatment of paediatric inflammatory diseases, including Crohn’s disease (6+ years), psoriasis (4+ years), enthesitis-related arthritis (6+ years) and polyarticular juvenile idiopathic arthritis (2+ years).

The approval was based on results from the pivotal phase III study VOLTAIRE-RA [2]. According to Boehringer, this study ‘demonstrated clinical equivalence in efficacy of BI 695501 to the reference product (Humira) in patients with moderate to severely active rheumatoid arthritis by meeting its primary endpoint’. The company added that the study also ‘showed no clinically meaningful differences between BI 695501 and Humira in terms of safety and immunogenicity’.

The approval marks Boehringer’s first biosimilar approved in Europe. However, Boehringer says that it does not intend to launch Cyltezo in the European Union ‘before expiration of the respective SPC for adalimumab in October 2018’. The patents on Humira will expire in the US in November 2017 and in Europe in June 2017 [3].

Cyltezo was also approved by the US Food and Drug Administration on 25 August 2017 [4].

Related article
Biosimilars of adalimumab

1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab and trastuzumab biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 17]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim’s adalimumab biosimilar ‘equivalent’ to Humira []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 17]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 17]. Available from:
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Cyltezo []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 17]. Available from:

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Source: Boehringer Ingelheim

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