● The European Commission has granted marketing authorisation for a biosimilar to Humira® for the treatment of multiple chronic inflammatory diseases
● Robust analytical, pharmacological, non–clinical & clinical data demonstrated the similarity of Cyltezo® to Humira®
● Approval follows recent positive CHMP opinion1 and FDA approval2 of Cyltezo®
INGELHEIM, Germany-Monday, November 13th 2017 [ AETOS Wire ]
(BUSINESS WIRE)-- Boehringer Ingelheim today 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
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.3
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Cyltezo® on September 14th, 20171 and on August 25th, 2017, Cyltezo® was approved by the U.S. Food and Drug Administration (FDA) in the United States (U.S.). 2
Cyltezo® is not commercially available in Europe or the U.S. 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. Boehringer Ingelheim is currently engaged in patent litigation with AbbVie in the U.S.
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
For references and notes to editors, please visit: http://www.boehringer-ingelheim.com/Marketing-Authorisation-granted-for-Cyltezo
Media + PR
Dr. Julia Knebel
Phone: +49 6132 – 77 95614
Fax: +49 6132 – 77 6601
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