Hospira’s Inflectra the first biosimilar monoclonal antibody to receive positive opinion from EMA’s CHMP for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis


Hospira’s Inflectra™ (infliximab) the monoclonal to opinion EMA’s CHMP for rheumatoid , inflammatory and
Announcement marks a major milestone in a new era of lower-cost biologic therapies

LEAMINGTON SPA, England, June 28, 2013 /PRNewswire/ — Hospira (NYSE: HSP), the world’s leading provider of injectable drugs and infusion technologies, today received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the European Commission (EC) approval of Inflectra (infliximab) for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.

Inflectra (infliximab) is a biosimilar medicine to the reference medicinal product, Remicade® (infliximab), and is the first monoclonal antibody therapy to reach a positive opinion following review via the EMA biosimilars regulatory pathway. A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic, with comparable quality, efficacy and safety to the reference product.[1] Remicade® had European sales of over USD 2bn in 2012.[2]

“Today’s announcement is confirmation that Inflectra has met the very rigorous quality, safety and efficacy requirements that have been established by the EMA, and provides the next step toward Inflectra being approved for use in Europe,” said Dr. Stan Bukofzer, Corporate Vice President and Chief Medical Officer, Hospira.

Biologic medicines have led to vast improvements in the treatment of conditions such as rheumatoid arthritis and inflammatory bowel disease, but they also represent one of the biggest medical expenditures in many countries.[3]

“In a time when there is mounting pressure on healthcare budgets worldwide, Inflectra provides an opportunity to increase patient access to more affordable biologic therapy while maintaining…Read more

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