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Sandoz Obtains Positive CHMP Opinion for Remicade Biosimilar
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Sandoz received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its proposed infliximab biosimilar for the treatment of all indications of its reference product across rheumatology, dermatology and gastroenterology, according to a manufacturer release.
“Sandoz is proud to be at the forefront of diversifying the biologics treatment landscape by bringing biosimilar medicines to market for patients living with devastating autoimmune diseases,” Richard Francis, chief executive officer of Sandoz, said in the release. “Today’s positive CHMP opinion marks a strong step forward in our efforts to accelerate patient access to biologics, and specifically infliximab, through our leading portfolio.”
The biosimilar, PF-06438179, is a chimeric human-murine monoclonal antibody targeted against tumor necrosis factor. The committee based its decision on data from the phase 3 REFLECTIONS study, which demonstrated the biosimilar’s equivalent efficacy to infliximab (Remicade, Janssen Biotech Inc.), as measured by the American College of Rheumatology 20 response at week 14.
If approved by the European Commission, the treatment will be granted centralized marketing authorization valid in the 28 countries of the European Union. Countries that are not members of the EU but part of the European Economic Area — Norway, Iceland and Liechtenstein — are expected to make corresponding decisions based on the European Commission’s recommendation, according to the release.
Sandoz acquired the biosimilar’s European development, commercialization and manufacturing rights from Pfizer in February 2016. Under the terms of the agreement, Pfizer retains commercialization and manufacturing rights to PF-06438179 in countries outside the European Economic Area.