The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Cyltezo, a Humira (adalimumab) biosimilar, for the treatment of multiple chronic inflammatory diseases, including severe active ankylosing spondylitis (AS).
The maker of Cyltezo, Boehringer Ingelheim, submitted a marketing authorization application (MAA) for the biosimilar following the August approval by the U.S. Food and Drug Administration (FDA). According to a press release, Cyltezo is not yet available in the U.S. “Boehringer Ingelheim is currently engaged in patent litigation with AbbVie in the U.S.,” the release states.
The MAA for Cyltezo was based on data from the pivotal Phase 3 study VOLTAIRE-RA (NCT02137226), which demonstrated clinical bioequivalence of Cyltezo (BI 695501) to Humira in people with moderate to severely active rheumatoid arthritis.
The trial met its primary endpoint, showing no clinically meaningful differences in efficacy, safety and immunogenicity between Humira and the biosimilar.
The CHMP has recommended the approval of Cyltezo for the following conditions:
- Severe active AS
- Severe axial spondyloarthritis without radiographic evidence of AS
- Moderate to severely active rheumatoid arthritis
- Psoriatic arthritis
- Moderate to severely active Crohn’s disease
- Moderate to severely active ulcerative colitis
- Moderate to severe chronic plaque psoriasis
- Moderate to severe hidradenitis suppurativa
- Non-infectious intermediate, posterior and panuveitis.
The CHMP also recommended the approval of Cyltezo for the treatment of certain pediatric inflammatory diseases. Age 6 and older, Crohn’s disease and enthesitis-related arthritis; age 4 and older, severe chronic plaque psoriasis; and age 2 and older, polyarticular juvenile idiopathic arthritis.
“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,” Ivan Blanarik, senior vice president and head of therapeutic area biosimilar at Boehringer, said in the press release.
“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 [Boehringer Ingelheim] 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,” he said.
A European Commission (EC) decision on the approval is expected in the fourth quarter of 2017.
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