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Europe recommends approval of generic version of J&J blockbuster, setting stage for competition

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European regulators are recommending approval of two copies of Remicade, a blockbuster rheumatoid arthritis drug made by Johnson & Johnson, a step that could lead to wider generic competition of biotechnology medicines.

A European Medicines Agency committee said today it supports European Union approval for two so-called biosimilar drugs: Remsima, made by South Korean company Celltrion Inc., and Inflectra, made by Illinois-based Hospira Inc.

The agency says those drugs can treat the same diseases as Remicade, including rheumatoid arthritis, Crohn's disease, psoriatic arthritis, psoriasis and other ailments.

Remicade, approved by the European Union in 1999, recorded more than $2 billion in European sales last year.

A spokesman for J&J subsidiary Jannsen Pharmaceuticals Inc., which makes Remicade, said more than 80 percent of European sales of the drug come from territories where the company maintains patent exclusivity through February 2015, limiting the amount of markets Hospira and Celltrion can initially enter.

Hospira and Celltrion say the positive opinion of the EMA will lead to cheaper prices in the long run.

"In a time when there is mounting pressure on health care budgets worldwide, Inflectra provides an opportunity to increase patient access to more affordable biologic therapy while maintaining high quality standards," Richard Davies, Hospira senior vice president and chief commercial officer, said in a statement.

The European Commission reviews recommendations made by the EMA's Committee for Medicinal Products for Human Use and normally decides on approval within three months.

Reporter Tom Zanki is @BizTZanki on Twitter.

Write to the Editorial Department at editorial@njbiz.com

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