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BIOSIMILARS

Hospira Gains First Biosimilar Approval in EU

Therapeutic developed with Celltrion will compete with Remicade.

MICHAEL FITZHUGH

The Burrill Report

“Inflectra is the first of eight biosimilars that Hospira agreed to develop and market with South Korea-based Celltrion in 2009.”

The European Commission approved Hospira’s Inflectra, Europe’s first biosimilar antibody for inflammatory diseases, putting it into competition with Janssen’s blockbuster Remicade.

The medicine will offer doctors, patients, and health systems a more affordable treatment option, says Hospira, though the company did not benchmark its price against Remicade, saying that pricing for it has not been established and may vary by country. Though generic drugs can offer savings of up to 90 percent on the cost of branded equivalents, savings from biosimilars are expected to be in the range of 20 to 30 percent.

“For over a decade biologic medicines have been pivotal in treating a range of inflammatory conditions, so the granting of marketing authorization in Europe is a major milestone for Inflectra, and for the future of biologic therapy,” says Stan Bukofzer, Hospira’s corporate vice president and CMO.

Inflectra is the first of eight biosimilars that Hospira agreed to develop and market with South Korea-based Celltrion in 2009. Hospira has exclusive rights to market the therapy in Europe, North America, Australia, and New Zealand. The companies agreed to collaborate on manufacturing and supply while independently commercializing any approved biosimilars under each party’s own brand name.

In June, the European Medicines Agency recommended approval for the Celltrion version of the biosimilar under the name Remsima. Both Remsima and Inflectra contain the same known active substance, infliximab.

Following the EMA’s recommendation, Beata Stepniewska, acting director general of the European Generic Medicines Association, called it “a key milestone in the history of medicines in the EU.” She said biosimilar medicines “provide real opportunities to reduce the cost of treatment with biopharmaceuticals without compromising the quality of healthcare that is delivered.”

Just like Remicade, Inflectra has been approved to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.



September 10, 2013
http://www.burrillreport.com/article-hospira_gains_first_biosimilar_approval_in_eu.html

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