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Hospira launches first biosimilar monoclonal antibody (mAb) Inflectra™ (infliximab) in major European markets

-- Major European markets can finally benefit from the availability of Inflectra following the patent expiry of reference product Remicade® (infliximab)
-- Inflectra provides an alternative, potentially more affordable treatment option for people suffering from severe, debilitating diseases such as rheumatoid arthritis and inflammatory bowel disease while maintaining comparable quality, efficacy and safety to the reference product
-- As a result of competition, the large savings expected to be generated with biosimilars can provide an opportunity to improve patient access to life-changing medications

A world leader in the development of biosimilar therapies, today announced the launch of the first 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 paediatric ulcerative colitis and plaque psoriasis.

Biologic medicines have transformed the lives of people living with chronic inflammatory conditions, such as RA and inflammatory bowel disease (IBD). However, biologics are responsible for some of the biggest medicinal costs across Europe and these high costs can restrict access to treatment. For example, it has been estimated that 40% of RA patients in Europe have severely restricted access to biologic treatment. Inflectra can offer a cost-effective alternative while maintaining the same quality, safety and efficacy as the reference product.

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

Infliximab is a cornerstone treatment for many inflammatory diseases, with over 15 years' worth of clinical data and experience. Inflectra is a biosimilar medicine to the reference product, Remicade® (infliximab), and is the first biosimilar mAb to be approved by the European Commission (EC). A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic.

Remicade (infliximab) has been authorized in the EU since 1999 and recorded European sales of almost €2 billion in 2013. The savings generated by introducing competition in the marketplace could save the European healthcare system millions of Euros, with biosimilars expected to produce savings of over €20 billion by 2020.

"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, Vice President Biologics, Hospira.

Inflectra received its license from the EC in September 2013, following adoption of the EMA Committee for Medicinal Products for Human Use (CHMP) positive recommendation for granting marketing authorization. Review by the EMA included detailed analysis of biophysical properties and safety, efficacy and tolerability data from an extensive preclinical and clinical trial program.

In a phase III randomized, double-blind study involving 606 patients, Inflectra met its primary endpoint of therapeutic equivalence to Remicade. In this study, using the ACR20 scoring system, 73.4% of patients receiving Inflectra achieved a greater than or equal to 20% improvement in RA symptoms after 30 weeks of treatment, compared with 69.7% treated with Remicade. In the same study, 42.3% of patients receiving Inflectra achieved a greater than or equal to 50% improvement in RA symptoms after 30 weeks of treatment (measured using the ACR50 scoring system), compared with 40.6% treated with Remicade. Comparable safety and tolerability data also demonstrated Inflectra's equivalence to Remicade. There were no marked differences in the immunogenicity profile of the two products up to 54 weeks, and the impact of anti-drug antibodies on efficacy and safety was comparable.

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 U.S. Food and Drug Administration for biosimilar infliximab.

With one of the largest biosimilar pipelines in the industry, Hospira has more than seven years' of market experience in biosimilars. The company has several biosimilars on the European market, including Inflectra (infliximab), Retacrit™ (epoetin zeta) and Nivestim™ (filgrastim). Hospira has delivered more than 10 million doses of biosimilar medicines to patients worldwide.

About Inflectra
Inflectra (infliximab) 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 α (TNF beta). Inflectra is indicated for:

Rheumatoid arthritis
Inflectra, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
adult patients with active disease when the response to disease?modifying antirheumatic drugs (DMARDs), including methotrexate, has been inadequate.
adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.

In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X?ray, has been demonstrated.

Adult Crohn's disease
Inflectra is indicated for:
treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).

Paediatric Crohn's disease
Inflectra is indicated for treatment of severe, active Crohn's disease in children and adolescents aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.

Ulcerative colitis
Inflectra is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6?mercaptopurine (6?MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.

Paediatric ulcerative colitis
Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6?MP or AZA, or who are intolerant to or have medical contraindications for such therapies.

Ankylosing spondylitis
Inflectra is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.

Psoriatic arthritis
Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.

Inflectra should be administered
in combination with methotrexate
or alone in patients who show intolerance to methotrexate or for whom methotrexate is contraindicated.

Infliximab has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X?ray in patients with polyarticular symmetrical subtypes of the disease.

Psoriasis
Inflectra is indicated for treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A (PUVA). 

See the Summary of Product Characteristics (also part of the EPAR) for full details.

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