Drugs Xagena
The European Commission ( EC ) has granted marketing authorization for Hulio, a biosimilar to Humira ( Adalimumab ), for all indications.
The authorization follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use ( CHMP ), which has concluded that the development program including analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with the reference product, Humira.
Hulio is indicated for the same indications of Humira, including: A) Adults: rheumatoid arthritis,
ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing, spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis,
uveitis; B) Children: polyarticular juvenile idiopathic arthritis ( age 2 and older ), enthesitis-related arthritis ( age 6 and older ), plaque psoriasis ( age 4 and older ), Crohn's disease ( age 6 and olde r), hidradenitis suppurativa ( age 12 and older ), uveitis ( age 2 and older ).
Adalimumab is an injectable, biologic medication which inhibits tumour necrosis factor ( TNF ). This can cause inflammation in autoimmune diseases such as rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis.
By specifically binding to TNF, Adalimumab blocks its activity, thereby reducing inflammation and other disease symptoms.
The full indication is:
Rheumatoid arthritis - Hulio in combination with Methotrexate, is indicated for: the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including Methotrexate has been inadequate; the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with Methotrexate.
Hulio can be given as monotherapy in case of intolerance to Methotrexate or when continued treatment with Methotrexate is inappropriate.
Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with Methotrexate.
Juvenile idiopathic arthritis - Polyarticular juvenile idiopathic arthritis - Hulio in combination with Methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs ( DMARDs ).
Hulio can be given as monotherapy in case of intolerance to Methotrexate or when continued treatment with Methotrexate is inappropriate.
Adalimumab has not been studied in patients aged less than 2 years.
Enthesitis-related arthritis - Hulio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.
Axial spondyloarthritis - Ankylosing spondylitis: Hulio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy; - Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis: Hulio is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of ankylosing spondylitis but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Psoriatic arthritis - Hulio is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.
Psoriasis - Hulio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Paediatric plaque psoriasis - Hulio is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Hidradenitis suppurativa - Hulio is indicated for the treatment of active moderate to severe hidradenitis suppurativa ( acne inversa ) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic therapy.
Crohn’s disease - Hulio 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.
Paediatric Crohn's disease - Hulio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients ( from 6 years of age ) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Ulcerative colitis - Hulio 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.
Uveitis - Hulio is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.
Paediatric Uveitis - Hulio is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate. ( Xagena )
Source: EMA, 2018
XagenaMedicine_2018
