infliximab (Remsima)

following a full submission:

infliximab (Remsima) is accepted for restricted use within NHSScotland.

Indication under review: Rheumatoid arthritis: in combination with methotrexate, for the reduction of signs and symptoms as well as 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.

Infliximab (Remsima) is also indicated in the following conditions: adult and paediatric Crohn’s disease and ulcerative colitis; adult psoriatic arthritis, psoriasis and ankylosing spondylitis.1

SMC restriction: infliximab (Remsima) is accepted for use in line with the current SMC and Healthcare Improvement Scotland advice for the reference product infliximab [Remicade].

A phase III, randomised, double-blind, parallel-group study demonstrated similar efficacy and safety of biosimilar infliximab with originator infliximab in patients with rheumatoid arthritis.

Infliximab (Remsima) is a biosimilar product to a reference product (infliximab [Remicade]).

The British National Formulary advises that it is good practice to prescribe biologic medicinal products by brand name.