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Home Industry News Hospira’s Inflectra receives CHMP recommendation

Hospira’s Inflectra receives CHMP recommendation

2nd July 2013

Hospira has announced that the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended its new biosimilar therapy Inflectra for approval.

The drug, which is based on the reference product Remicade, has been endorsed as a potential new therapy for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis, based on positive phase III trial data.

It is the first monoclonal antibody therapy to gain a positive CHMP opinion following review via the EMA biosimilars regulatory pathway and has been shown to deliver a comparable level of quality and effectiveness to the original product.

Dr Stan Bukofzer, corporate vice-president and chief medical officer at Hospira, said: "Today's announcement is confirmation that Inflectra has met the very rigorous quality, safety and efficacy requirements that have been established by the EMA."

The company marked the fifth anniversary of the launch of its biosimilar portfolio in Europe earlier this year and is now introducing the products in the US market for the first time.ADNFCR-8000103-ID-801607225-ADNFCR

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