Hospira introduces first biosimilar mAb Inflectra in some European markets

Inflectra is a chimeric human murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNF alpha but not to lymphotoxin a (TNF beta).

It is indicated 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.

Medical University of Vienna chairman of the Division of Rheumatology professor Josef Smolen said: "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.

"Biosimilars that underwent assessment and approval by the European Commission have been included in the latest EULAR treatment recommendations."

Inflectra, a biosimilar medicine to the reference product Remicade (infliximab), is the first biosimilar mAb to be approved by the European Commission (EC).

Hospira vice president Biologics 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."

In Europe, Inflectra secured its license following adoption of positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for granting marketing authorization.

The company said that in a Phase III randomized, double-blind trial involving 606 patients, Inflectra met its primary endpoint of therapeutic equivalence to Remicade.

Currently, Inflectra is being introduced in several major European markets, including Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain and Sweden.