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Hospira Shares Results From Two Open-label Extension Studies for Biosimilar Infliximab in Patients With Rheumatoid Arthritis or Ankylosing Spondylitis
Date:10/31/2013

first monoclonal antibody (mAb) to be approved through the EMA biosimilars regulatory pathway. A biosimilar developed in line with EU requirements can be considered a therapeutic alternative to an existing biologic in Europe. Inflectra is not currently approved for use in the United States.

In the EU, 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 thera
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SOURCE Hospira, Inc.
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