US-based pharmaceutical firm Hospira has introduced its first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets.
Inflectra has been licensed to treat inflammatory conditions, including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, adult and paediatric ulcerative colitis and plaque psoriasis.
According to Hospira, Inflectra is a biosimilar medicine to the reference product, Remicade (infliximab).
It is a chimeric human murine monoclonal antibody, which binds with high affinity to both soluble and transmembrane forms of TNF alpha.
Hospira biologics vice-president Paul Greenland said: "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.
"We are delighted that the remaining European countries, including many of the major EU countries, will now benefit from the availability of Inflectra."
Inflectra is said to be launched in major European markets such as Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain and Sweden. It is now available in 24 European countries, with the launch of the product in these new markets.
The European Commission (EC) approved Inflectra in September 2013, following acceptance of the EMA Committee for Medicinal Products for Human Use (CHMP) positive recommendation for granting marketing authorisation.
Inflectra reached its primary endpoint of therapeutic equivalence to Remicade in a Phase III randomised and double-blind study involving 606 patients.
Hospira’s partner Celltrion also submitted an application to the US Food and Drug Administration for biosimilar infliximab.
Image: Hospira headquarters. Photo: courtesy of Acherubini2020.