Hospira Launches First Biosimilar Monoclonal Antibody for Adult & Pediatric Crohn’s, Ulcerative Colitis In Europe

Hospira Launches First Biosimilar Monoclonal Antibody for Adult & Pediatric Crohn’s, Ulcerative Colitis In Europe

hospiraHospira, Inc.a biotechnology company developing biosimilar therapies, has recently announced the launch of Inflectra (infliximab), the first biosimilar monoclonal antibody (mAb), in major European markets. Inflectra is licensed to address several inflammatory conditions such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, adult and pediatric Crohn’s disease, and adult and pediatric ulcerative colitis.

The company claims that while the lives of those living with chronic inflammatory conditions like inflammatory bowel disease or rheumatoid arthritis are being transformed thanks to biologic medicines, they are also responsible for some of the highest healthcare costs in Europe, restricting treatment access. For instance, estimates show that about 40 percent of patients suffering from RA in Europe are not always being prescribed biologic treatments due to costs. To address this gap, Inflectra will provide a cost-effective alternative to medicinal reference products without compromising quality, efficacy and safety.

Professor Josef Smolen, the Chairman of the Rheumatology Division at Medical University of Vienna, said in a press release: “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.”

Touted as one of the most effective IBD therapies, development of Infliximab involved more than 15 years of clinical data and experiments. Inflectra is a biosimilar medicine to reference product Remicade® (infliximab), and is the first biosimilar mAb to be approved by the European Commission (EC). Remicade was originally cleared in the EU in 1999 and accounted for €2 billion in European sales in 2013. It is expected that in 2020 it will bring in over €20 billion in sales.

“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. This supports Hospira’s commitment to provide patients with better access to high-quality, more affordable care,” said Paul Greenland, Hospira’s representative.

Inflectra received an EC license in 2013 and an EMA positive recommendation based on a phase III double-blind, randomized study that enrolled 606 patients to demonstrate the tolerability data, safety and equivalence of Inflectra to Remicade.

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