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Zessly ( Infliximab ), biosimilar of Remicade, recommended for approval in the EU

On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Zessly, intended for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. The applicant for this medicinal product is Sandoz GmbH.

Zessly will be available as a 100 mg powder for concentrate for solution for infusion. The active substance of Zessly is infliximab, a tumour necrosis factor alpha (TNF-α) inhibitor. Infliximab is a chimeric human murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNF-α.

Zessly is a biosimilar medicinal product. It is highly similar to the reference product Remicade (infliximab), which was authorised in the EU on 13 August 1999. Data show that Zessly has comparable quality, safety and efficacy to Remicade (infliximab).

The full indication is:

“Rheumatoid arthritis

Zessly, 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

Zessly 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

Zessly 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

Zessly 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

Zessly 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

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

Psoriatic arthritis

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

Zessly 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 (see section 5.1).

Psoriasis

Zessly 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 PUVA (see section 5.1).”

It is proposed that Zessly is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis.

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