Hospira has announced the European Commission ( EC ) approval of Inflectra ( Infliximab ), Europe's first biosimilar monoclonal antibody (mAb) therapy. Inflectra has been approved for the treatment of inflammatory conditions including rheumatoid arthritis ( RA ), ankylosing spondylitis, Crohn's disease ( CD ), ulcerative colitis ( UC ), psoriatic arthritis ( PsA ) and psoriasis.

Inflectra is a biosimilar medicine to the reference medicinal product, Remicade ( Infliximab ), and is the first monoclonal antibody to be approved through the European Medicines Agency ( EMA ) biosimilars regulatory pathway. A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic. Remicade recorded European sales of over USD 2 billion in 2012.

The use of biologic medicines has led to vast improvements in the treatment of conditions such as rheumatoid arthritis and inflammatory bowel disease, but these drugs are also responsible for some of the highest medicinal costs for many countries. The introduction of biosimilar mAbs in Europe is expected to deliver savings of up to € 20.4 billion by 2020, with the biggest savings predicted in France, Germany and the UK.

Inflectra was approved by the EC following review of safety, efficacy and tolerability data from a comprehensive clinical trial programme. In a phase III randomised, double-blind study, Inflectra met its primary endpoint of therapeutic equivalence to Remicade. In the study, 73.4% of patients receiving Inflectra achieved a greater than or equal to 20% improvement in RA symptoms after 30 weeks of treatment ( measured using the ACR20 scoring system ), compared with 69.7% treated with Remicade.
Safety and tolerability data also demonstrated Inflectra's equivalence to Remicade. The most common side effects are viral infections, headache, upper respiratory-tract infection, sinusitis, nausea, abdominal pain, infusion-related reactions and pain.

Inflectra is indicated for:

a) 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.

b) Crohn's disease - Inflectra is indicated for the 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 ).
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.

c) 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.
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.

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

e) 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.

f) 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 ). ( Xagena )

Source: Hospira, 2013

XagenaMedicine2013