Hospira launches first mAb biosimilar in major EU markets

By Zachary Brennan contact

- Last updated on GMT

Hospira launch biosimilar mAb in the EU
Hospira launch biosimilar mAb in the EU

Related tags: European medicines agency, Rheumatoid arthritis, Infliximab

Hospira, recently acquired by Pfizer, announced Monday the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets, following the patent expiry of J&J’s Remicade. 

First approved​ by the European Medicines Agency’s Committee for Medicinal Products for Human Use in June 2013, the biosimilar is expected to save EU countries millions of dollars, though Hospira has yet to indicate what the cost of the biosimilar will be. J&J’s Remicade (infliximab) recorded European sales of almost €2bn ($2.3bn) in 2013. 

Hospira has yet to disclose a price, but analysts expect it could be 20% to 30% cheaper than brand Remicade, according to Forbes​.

Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain and Sweden will now see new cost savings from the biosimilar.

Central and Eastern Europe​ have been using Inflectra since last February. With the launch of the product in these new markets, Inflectra is now available in 24 European countries. Hospira's partner, Celltrion, has also submitted an application to the US FDA for biosimilar infliximab.

"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, VP Biologics, Hospira.

Inflectra is licensed for the treatment of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn's disease, adult and paediatric ulcerative colitis and plaque psoriasis.

Hospira’s Inflectra, however, is not the first mAb to be approved worldwide as Remsima (infliximab) won approval in Korea last year.

"With more and more people living with chronic inflammatory diseases like RA, we need to find more cost-effective treatment solutions without compromising on quality, safety or efficacy. Biosimilars could offer one such solution – savings could mean we can treat more patients within the same healthcare budget​," said Professor Josef Smolen, Chairman of the Division of Rheumatology at Medical University of Vienna.

Hospira has several other biosimilars on the European market, including Retacrit (epoetin zeta) and Nivestim (filgrastim). 

Related topics: Markets & Regulations, Biosimilars

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