Hospira Launches Biosimilar Remicade in EUBy
Hospira has launched a biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets. Inflectra is licensed for the treatment of inflammatory conditions, including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, adult and pediatric ulcerative colitis and plaque psoriasis.
Inflectra is a biosimilar medicine to the reference product, Johnson & Johnson’s Remicade (infliximab). Hospira’s biosimilar of infliximab was approved by the European Commission in 2013. Remicade has been authorized in theEuropean Union since 1999 and recorded European sales of almost EUR 2 billion ($2.28 billion) in 2013, according to information from Hospira.
Inflectra is being launched in several major European markets, including Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain, and Sweden. 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 Food and Drug Administration for biosimilar infliximab.
See related story, “FDA Advisory Committee Sets Date for Reviewing Remicade Biosimilar.”