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Hospira launches first Remicade biosimilar product in European markets

Hospira has announced the launch of Inflectra, the first biosimilar monoclonal antibody, in major European markets for the treatment of adult plaque psoriasis, psoriatic arthritis, rheumatoid arthritis and ankylosing spondylitis, as well as adult and pediatric Crohn’s disease and ulcerative colitis.

Inflectra, a biosimilar medicine to Remicade (infliximab, Janssen Biotech), is the first biosimilar monoclonal antibody to be approved to the European Commission (EC), according to a company press release.
The EC licensed Inflectra, which can be considered a therapeutic alternative to an existing biologic, in September 2013 following the adoption of the EMA Committee for Medicinal Products for Human Use’s positive recommendation for granting marketing authorization, according to the release.

Analysis of biophysical properties and safety, efficacy and tolerability data from a preclinical and clinical trial program were reviewed by the EMA. Inflectra met the primary endpoint of therapeutic equivalence to Remicade in a phase 3, double-blind, randomized trial of 606 patients with rheumatoid arthritis.

European markets in which Inflectra is being launched include Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden, for a total of 24 European countries in which the product is available, the release stated.

Celltrion, Hospira’s partner, has submitted an application to the FDA for biosimilar infliximab, according to the release.

Reference: www.hospira.com.