First Hospira Biosimilar mAb Approved in West Europe

Published on: 

Hospira’s Inflectra (infliximab), a biosimilar for Remicade, is approved by the European Commission.

Immediately following its acquisition by Pfizer, Hospira announced a major milestone on Feb. 16, 2015:  its first monoclonal antibody (mAb) biosimilar was approved for use in West Europe. Despite the elusive wording in the press release, it is not the first time Inflectra will be in use throughout Europe.

"Inflectra has already been launched in Central and Eastern Europe, and some smaller Western European markets due to earlier patent expiry, and has already been prescribed to treat patients in all its licensed indications,” said Paul Greenland, vice-president of biologics, Hospira, in a statement. “We are delighted that the remaining European countries, including many of the major EU countries, will now benefit from the availability of Inflectra." Inflectra will now be available in 24 European countries.

Hospira’s Inflectra is approved to treat a range of inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and psoriasis.

Inflectra got the nod from the European Commission (EC) in September 2013 following a positive recommendation for marketing authorization. Savings from the biosimilar is estimated to save the European healthcare system more than 20 billion euros (approximately US$2.3 billion) by 2020; most of these savings are thought to come from increased competition with Remicade, which has dominated the market in the EU since 1999. Forbes estimates Inflectra will be sold at a 20–30% discount to Johnson & Johnson’s Remicade (infliximab).


Inflectra is not technically the first mAb to be approved worldwide. Hospira's partner, the South Korean firm Celltrion, gained approval for Remsima (infliximab) in Korea in 2012. In 2013, Remsima and Inflectra were the world's first biosimilar mAbs to be approved by the European Medicines Agency, according to Regulatory Affairs Professionals Society.

Celltrion has also submitted an application to FDA for a biosimilar version of infliximab. An FDA advisory committee will review Celltrion's Remsima on March 17, 2015, and it is believed to become the second follow-on biologic to reach the market in the United States.

PR Newswire