Type of information: Granting of a Market Authorisation in the EU
Product name: Zessly®
Compound: biosimilar version of infliximab (Remicade®)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases - Digesti
- biosimilar/monoclonal antibody/TNF alpha inhibitor. Infliximab is a tumour necrosis factor alpha (TNF-?) inhibitor. This chimeric human murine monoclonal antibody binds with high affinity to both soluble and transmembrane forms of TNF-alpha.
- 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.
Company: Sandoz (Switzerland)
- ulcerative colitis, Crohn's disease, psoriasis, ankylosing spondylitis, psoriatic arthritis, juvenile idiopathic arthritis, rheumatoid arthritis
- • On May 18, 2018, Sandoz, a Novartis division and the global leader in biosimilars, announced that the European Commission (EC) has approved Zessly® (infliximab) for use in Europe. Zessly is approved for use in all indications of the reference medicine Remicade® including rheumatoid arthritis, adult Crohn's disease, pediatric Crohn's disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
- The EC approval was based on review of a comprehensive development program, including analytical, preclinical and clinical data, which confirmed Zessly® matched its reference medicine in terms of safety, efficacy and quality. The clinical Phase III confirmatory study in rheumatoid arthritis (REFLECTIONS B537-02) met its primary endpoint, demonstrating equivalent efficacy of Zessly® to the reference medicine as measured by the American College of Rheumatology 20 (ACR20) response at Week 14.
- • 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 Zessly®, intended for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. The drug will be available as a 100 mg powder for concentrate for solution for infusion. Data show that Zessly® has comparable quality, safety and efficacy to Remicade® (infliximab). The full indication is:
- Rheumatoid arthritis, 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 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
- - 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 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.
- - 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 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 in adult patients who
have responded inadequately to conventional therapy.
- 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
- - 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
- • On May 31, 2017, Sandoz, a Novartis division, announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorization Applications for biosimilar to Janssen’s Remicade® (infliximab) which is used to treat immunological diseases. Sandoz is seeking approval for biosimilar infliximab for use in all indications of its reference medicine. The comprehensive data packages included in the EMA submission demonstrate biosimilarity of the proposed biosimilar to its respective reference medicine, with analytical, preclinical and clinical data matching across quality, efficacy and safety. The biosimilar infliximab submission included clinical data from a PK study and a Phase III confirmatory efficacy and safety, study in rheumatoid arthritis.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
UE authorization: 2018--05-18
Favourable opinion UE: 2018-03-22
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: