Boehringer Ingelheim has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo® (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children.
The decision of the European Commission on the approval is expected in the fourth quarter of 2017.
“The recommendation by the CHMP for Cyltezo® is an important milestone for Boehringer Ingelheim, bringing us one step closer to providing our first biosimilar to healthcare providers and patients” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Chronic inflammatory diseases can be incredibly debilitating and we are delighted that Cyltezo® has the potential to improve the lives of many of these patients. BI is committed to supporting the long-term potential of biosimilars, which we believe will be a key contributor to the future sustainability of healthcare systems around the world.”
The CHMP has recommended the approval of Cyltezo® for multiple chronic inflammatory diseases including, in adults:
- Moderate to severely active rheumatoid arthritis
- Psoriatic arthritis
- Moderate to severely active Crohn’s disease
- Severe active ankylosing spondylitis
- 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.
The CHMP also recommends approval of Cyltezo® 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 Application (MAA) for Cyltezo® was based on a comprehensive data package supporting the biosimilarity of Cyltezo® to Humira® (adalimumab) based on analytical, pharmacological, non-clinical and clinical data, including results from the pivotal Phase III study VOLTAIRE®-RA, which demonstrated clinical equivalence of BI 695501 to the reference product in people with moderate to severely active rheumatoid arthritis. The pivotal phase III study met its primary endpoint showing no clinically meaningful difference in efficacy between BI 695501 and Humira® in terms of safety and immunogenicity.2
- Brennan, Zachary. 2017. FDA Approved 6th Biosimilar in US, Second for Humira. Regulatory Affairs Professionals Society. http://www.raps.org/Regulatory-Focus/News/2017/08/28/28340/FDA-Approves-…. [Accessed: September, 2017]
- 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.