Boehringer Ingelheim has announced that the European Commission has granted marketing authorisation for Cyltezo® a biosimilar to Humira® for the treatment of multiple chronic inflammatory diseases in adults and children.
“Cyltezo® is the first biosimilar from Boehringer Ingelheim approved in Europe, and marks a significant step forward for us in offering effective, and more affordable treatment options for patients with chronic inflammatory diseases,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Boehringer Ingelheim has been an industry leader in the production of biologics for 35 years, and we are delighted to have applied this expertise to the development of Cyltezo®. We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world.”
Cyltezo® has been approved for the treatment of multiple chronic inflammatory diseases in adults, including:
- Moderate to severely active rheumatoid arthritis
- Psoriatic arthritis
- Moderate to severely active Crohn’s disease
- Severe active ankylosing spondylitis (AS)
- Moderate to severely active ulcerative colitis
- Severe axial spondyloarthritis without radiographic evidence of AS
- Moderate to severe chronic plaque psoriasis
- Moderate to severe hidradenitis suppurativa
- Non-infectious intermediate, posterior and panuveitis.
Cyltezo® has also been granted marketing authorisation for the treatment of paediatric inflammatory diseases, including moderate to severe Crohn’s disease (age six and older), severe chronic plaque psoriasis (age four and older), enthesitis-related arthritis (age six and older) and polyarticular juvenile idiopathic arthritis (age two and older).
The marketing authorisation of Cyltezo® was based on a comprehensive data package supporting the biosimilarity of Cyltezo® to Humira® comprising analytical, pharmacological, non-clinical and clinical data.
This included results from the pivotal Phase III study VOLTAIRE®-RA, which demonstrated clinical equivalence in efficacy of BI 695501 to the reference product in patients with moderate to severely active rheumatoid arthritis by meeting its primary endpoint. Additionally the study showed no clinically meaningful differences between BI 695501 and Humira® in terms of safety and immunogenicity.1
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Cyltezo® on 14 September, 2017 and on 25 August, 2017, Cyltezo® was approved by the US Food and Drug Administration (FDA) in the US.2
Cyltezo® is not commercially available in Europe or the US at this time. In any event Boehringer Ingelheim does not intend to launch Cyltezo® in the EU before expiration of the respective SPC for adalimumab in October 2018.
- Ramael S, et al. Similar pharmacokinetics, safety and tolerability of the Humira (adalimumab) biosimilar candidate BI 695501 administered subcutaneously via prefilled syringe (PFS) or autoinjector (AI) (VOLTAIRE-AI). Abstract presented at EULAR, Madrid, June 14-17 2017.
- U.S. Food & Drug Administration. 2017. Drugs@FDA: FDA Approved Drug Products. Available at: www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process…. [Accessed: November, 2017].