EMA Committee Backs Remicade Biosimilar Zessly

Megan Brooks

March 23, 2018

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use has recommended in favor of marketing the infliximab biosimilar product Zessly, from Sandoz GmbH, for treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

Studies have shown Zessly to have "comparable quality, safety and efficacy" to the reference product Remicade (infliximab, Janssen Biotech, Inc), the EMA said in a statement. Infliximab is a tumor necrosis factor alpha blocker. Zessly will be available as a 100-mg powder for concentrate for solution for infusion. 

For rheumatoid arthritis, Zessly is indicated in combination with methotrexate to reduce signs and symptoms and improve physical function in adults with active disease who have failed to respond adequately to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, as well as in adults 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.

For Crohn's disease, Zessly is indicated for moderately to severely active disease in adults who have not responded to 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. It i's also indicated for treatment of fistulizing, active Crohn's disease in adults who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage, and immunosuppressive therapy).

For pediatric Crohn's disease, Zessly is indicated for severe, active disease in children and adolescents aged 6 to 17 years who have not responded to conventional therapy or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy, the EMA notes.

For ulcerative colitis in adults and children aged 6 to 17 years, Zessly is indicated for treatment of moderately to severely active disease in patients who fail standard therapies or who are intolerant to or have medical contraindications to such therapies.

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

For psoriatic arthritis, Zessly is indicated for active and progressive disease in adults when the response to previous DMARD therapy has been inadequate. Zessly should be administered with methotrexate or alone in patients who are intolerant 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," the EMA says.

For psoriasis, Zessly is indicated for moderate-to-severe plaque psoriasis in adults who fail to respond to or who have a contraindication to or are intolerant to other systemic therapy including cyclosporine, methotrexate, or psoralen and ultraviolet A (PUVA) therapy.

Zessly should 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, the EMA advises.

The summary of product characteristics will provide detailed recommendations for the use of Zessly. It will be published in all official European Union languages in the European public assessment report after the European Commission grants marketing authorization.

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