- 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, 13 November 2017 – 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
- 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.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.
About Boehringer Ingelheim in Biologics and Biosimilars
Boehringer Ingelheim is one of the largest producers of biologic medicines in the world. As a pioneer in biologics with more than 35 years of experience, the company has manufactured more than 25 biologic medicines for global markets. This includes monoclonal antibodies in immunology and oncology, interferons, and other targeted medicines that are routinely used to treat many patients across a broad range of therapeutic areas.
Boehringer Ingelheim further builds on its commitment to immunology and oncology to develop biosimilars as high quality, safe, and effective treatment options to patients with autoimmune diseases and cancer.
Boehringer Ingelheim currently has two biosimilar monoclonal antibodies in late stage development: Cyltezo®
a biosimilar to Humira®
and BI 695502, bevacizumab biosimilar candidate to Avastin®
.* All public information on our clinical trials is available on: http://clinicaltrials.gov/
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, some 50,000 employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. In 2016, Boehringer Ingelheim achieved net sales of around 15.9 billion euros. With more than three billion euros, R&D expenditure corresponds to 19.6 per cent of net sales.
Social responsibility comes naturally to Boehringer Ingelheim. That is why the company is involved in social projects such as the “Making More Health” initiative. Boehringer Ingelheim also actively promotes workforce diversity and benefits from its employees’ different experiences and skills. Furthermore, the focus is on environmental protection and sustainability in everything the company does.
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.
*Humira® is a registered trademark of AbbVie Biotechnology Ltd. and Avastin® is a registered trademark of Genentech, Inc. (USA).
1 European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14 September 2017. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2.... [Accessed: November, 2017]
2 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].
3 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.