Biosimilari approvati dall'EMA

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Medicine Name Active Substance Common name Atc code Marketing Authorisation Holder Authorisation date Indication
Abasaglar (previously Abasria) insulin glargine insulin glargine A10AE04 Eli Lilly Regional Operations GmbH 09/09/2014 Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Abseamed epoetin alfa epoetin alfa B03XA01 Medice Arzneimittel Pütter GmbH & Co. KG 28/08/2007 Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:

treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;
treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.

Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre existing anaemia at the start of chemotherapy).
Abseamed can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (haemoglobin (Hb) 10-13 g/dl [6.2-8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Abseamed can be used to reduce exposure to allogeneic blood transfusions in adult non iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with an expected blood loss of 900 to 1800 ml.
Accofil filgrastim filgrastim L03AA02 Accord Healthcare Ltd 18/09/2014 Accofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Accofil are similar in adults and children receiving cytotoxic chemotherapy. Accofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of  0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Accofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Amgevita adalimumab adalimumab L04AB04 Amgen Europe B.V. 22/03/2017 Please refer to section 4.1 of the Summary of product characteristics in the product information document
Bemfola follitropin alfa follitropin alfa G03GA05 Gedeon Richter Plc. 27/03/2014 In adult women:

anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate;
stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT);
follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level  1.2 IU/l.

In adult men:

follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.
Benepali etanercept etanercept L04AB01 Samsung Bioepis UK Limited (SBUK)
Regus Building 
3000 Hillswood Drive 
Surrey 
Chertsey KT16 0RS
United Kingdom
14/01/2016 Rheumatoid arthritis


Benepali in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Benepali, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.

Psoriatic arthritis


Treatment of active and progressive psoriatic arthritis in adults when the response to previous diseasemodifying antirheumatic drug therapy has been inadequate. Etanercept 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.


Axial spondyloarthritis


Ankylosing spondylitis Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.


Non-radiographic axial spondyloarthritis


Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).


Plaque psoriasis


Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).


Ankylosing spondylitis


Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.


Non-radiographic axial spondyloarthritis


Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).


Plaque psoriasis


Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA).
Binocrit epoetin alfa epoetin alfa B03XA01 Sandoz GmbH 28/08/2007 Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:

treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;
treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis;
Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Epoetin Alfa Hexal epoetin alfa epoetin alfa B03XA01 Hexal AG 28/08/2007 Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:

treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;
Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.

Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Erelzi etanercept etanercept L04AB01 Sandoz GmbH 23/06/2017 Rheumatoid arthritis
Erelzi in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to diseasemodifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate.
Erelzi can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Erelzi is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Etanercept, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by Xray and to improve physical function.
Juvenile idiopathic arthritis
Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of psoriatic arthritis in adolescents from the age of 12years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Treatment of enthesitisrelated arthritis in adolescents from the age of 12years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.
Etanercept has not been studied in children aged less than 2years.
Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when the response to previous diseasemodifying antirheumatic drug therapy has been inadequate. Etanercept 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 Xray in patients with polyarticular symmetrical subtypes of the disease.
Axial spondyloarthritis
Ankylosing spondylitis (AS)
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Nonradiographic axial spondyloarthritis
Treatment of adults with severe nonradiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated Creactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal antiinflammatory drugs (NSAIDs).
Plaque psoriasis
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultravioletA light (PUVA).
Paediatric plaque psoriasis
Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
Filgrastim Hexal filgrastim filgrastim L03AA02 Hexal AG 06/02/2009
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Mobilisation of peripheral blood progenitor cells (PBPCs).
In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of of  0.5 x 109/l, and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Treatment of persistent neutropenia (ANC  0.5 x 109/l), and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
Flixabi infliximab infliximab L04AB02 Samsung Bioepis UK Limited (SBUK) 26/05/2016 Rheumatoid arthritis
Flixabi, 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.
dult 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 (see section 5.1).
Adult Crohns disease
Flixabi is indicated for:

reatment of moderately to severely active Crohns 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.
reatment of fistulising, active Crohns 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 Crohns disease
Flixabi is indicated for treatment of severe, active Crohns 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
Flixabi 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
Flixabi 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
Flixabiis indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Psoriatic arthritis
Flixabi is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Flixabi 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
Flixabi 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 psoralen ultra-violet A (PUVA) (see section 5.1).
Grastofil filgrastim filgrastim L03AA02 Apotex Europe BV 18/10/2013 Grastofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
The safety and efficacy of Grastofil are similar in adults and children receiving cytotoxic chemotherapy.
Grastofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of  0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Grastofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Grastofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Inflectra infliximab infliximab L04AB02 Hospira UK Limited 10/09/2013 Rheumatoid arthritis
Inflectra, 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 diseasemodifying 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 Xray, has been demonstrated.
Adult Crohns disease
Inflectra is indicated for:

treatment of moderately to severely active Crohns 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 Crohns 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 Crohns disease
Inflectra is indicated for treatment of severe, active Crohns disease in children and adolescents agedsix to 17years, 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
Inflectra 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 6mercaptopurine (6MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Paediatric ulcerative colitis
Inflectra is indicated for treatment of severely active ulcerative colitis in children and adolescents agedsix to 17years, who have had an inadequate response to conventional therapy including corticosteroids and 6MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Ankylosing spondylitis
Inflectra is indicated for treatment of severe, active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
Psoriatic arthritis
Inflectra is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Inflectra 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 Xray in patients with polyarticular symmetrical subtypes of the disease.
Psoriasis
Inflectra 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 psoralen ultra-violet A (PUVA).
Inhixa enoxaparin sodium enoxaparin sodium B01AB05 Techdow Europe AB 15/09/2016 Inhixa is indicated for adults for:

Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery.
Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL).
Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism.
Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA).
Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
Blood clot prevention in the extracorporeal circulation during haemodialysis.
Lusduna insulin glargine insulin glargine A10AE04 Merck Sharp & Dohme Limited 04/01/2017 Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Movymia teriparatide teriparatide H05AA02 STADA Arzneimittel AG 11/01/2017 Movymia is indicated in adults.Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture (see section 5.1). In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture (see section 5.1).
Nivestim filgrastim filgrastim L03AA02 Hospira UK Ltd
 
08/06/2010 Filgrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia.
The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Filgrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l and a history of severe or recurrent infections, long-term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Filgrastim is indicated for the treatment of persistent neutropenia (ANC 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Omnitrope somatropin somatropin H01AC01 Sandoz GmbH 12/04/2006 Infants, children and adolescents

Growth disturbance due to insufficient secretion of growth hormone (GH).
Growth disturbance associated with Turner syndrome.
Growth disturbance associated with chronic renal insufficiency.
Growth disturbance (current height standard-deviation score (SDS)  -2.5 and parental adjusted SDS  -1) in short children / adolescents born small for gestational age (SGA), with a birth weight and / or length below -2 standard deviations (SDs), who failed to show catch-up growth (height velocity (HV) SDS  0 during the last year) byfour years of age or later.
Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing.

Adults

Replacement therapy in adults with pronounced growth hormone deficiency. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (SDS  -2) who may be considered for one test. The cut-off point of the dynamic test should be strict.
Ovaleap follitropin alfa follitropin alfa G03GA05 Teva Pharma B.V. 27/09/2013 In adult women

Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate;
Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer;
Ovaleap in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level  1.2 IU/L.

In adult men

Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
Ratiograstim filgrastim filgrastim L03AA02 Ratiopharm GmbH 15/09/2008 Ratiograstim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Ratiograstim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of  0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Ratiograstim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Ratiograstim is indicated for the treatment of persistent neutropenia (ANC  1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Remsima infliximab infliximab L04AB02 Celltrion Healthcare Hungary Kft. 10/09/2013 Rheumatoid arthritis
Remsima, 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 Crohns disease
Remsimais indicated for:

treatment of moderately to severely active Crohns 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 Crohns 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 Crohns disease
Remsimais indicated for treatment of severe, active Crohns disease in children and adolescents agedsix to 17years, 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
Remsimais 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
Remsimais indicated for treatment of severely active ulcerative colitis in children and adolescents agedsix to 17years, 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
Remsimais indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Psoriatic arthritis
Remsimais indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Remsima 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.
Psoriasis
Remsimais 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 psoralen ultra-violet A (PUVA).
Retacrit epoetin zeta epoetin zeta B03XA01 Hospira UK Limited 18/12/2007
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:

treatment of anaemia associated with chronic renal failure in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis;
treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis.


Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre-existing anaemia at the start of chemotherapy).
Retacrit can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood-saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (four or more units of blood for females orfive or more units for males).
Retacrit can be used to reduce exposure to allogeneic blood transfusions in adult non-iron-deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with expected moderate blood loss (900 to 1800 ml).
Silapo epoetin zeta epoetin zeta B03XA01 Stada Arzneimittel AG 18/12/2007
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:

treatment of anaemia associated withCRF in adult and paediatric patients on haemodialysis and adult patients on peritoneal dialysis (see section 4.4);
Treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis (see section 4.4);


treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre‑existing anaemia at the start of chemotherapy).
Silapo can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males).
Solymbic adalimumab adalimumab L04AB04 Amgen Europe B.V. 22/03/2017 Please refer to section 4.1 of the Summary of product characteristics in the product information document. 
Terrosa teriparatide teriparatide H05AA02 Gedeon Richter Plc. 04/01/2017 Terrosa is indicated in adults.
Treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.
Treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.
Tevagrastim filgrastim filgrastim L03AA02 Teva GmbH 15/09/2008 Tevagrastim is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells (PBPC).
In patients, children or adults, with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of Tevagrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Tevagrastim is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.
Thorinane enoxaparin sodium enoxaparin sodium B01AB05 Pharmathen S.A. 15/09/2016 Thorinane is indicated for adults for:
- Prophylaxis of venous thromboembolism, particularly in patients undergoing orthopaedic, general or oncological surgery.
- Prophylaxis of venous thromboembolism in patients bedridden due to acute illnesses including acute heart failure, acute respiratory failure, severe infections, as well as exacerbation of rheumatic diseases causing immobilisation of the patient (applies to strengths of 40 mg/0.4 mL).
- Treatment of deep vein thrombosis (DVT), complicated or uncomplicated by pulmonary embolism.
- Treatment of unstable angina and non Q wave myocardial infarction, in combination with acetylsalicylic acid (ASA).
- Treatment of acute ST segment elevation myocardial infarction (STEMI) including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
- Blood clot prevention in the extracorporeal circulation during haemodialysis.
Prevention and treatment of various disorders related to blood clots in adults.
Truxima rituximab rituximab L01XC02 Celltrion Healthcare Hungary Kft. 17/02/2017 Truxima is indicated in adults for the following indications: Non-Hodgkins lymphoma (NHL)Truxima is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy.Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.Truxima monotherapy is indicated for treatment of patients with stage III IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy.Truxima is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkins lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.Chronic lymphocytic leukaemia (CLL)Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Truxima or patients refractory to previous Truxima plus chemotherapy.See section 5.1 for further information.Rheumatoid arthritisTruxima in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease modifying anti rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.Truxima 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.Granulomatosis with polyangiitis and microscopic polyangiitisTruxima, in combination with glucocorticoids, is indicated for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegeners) (GPA) and microscopic polyangiitis (MPA).
Zarzio filgrastim filgrastim L03AA02 Sandoz GmbH 06/02/2009
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.
Mobilisation of peripheral blood progenitor cells (PBPC).
In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of 0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.
Treatment of persistent neutropenia (ANC  1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
*DATI AGGIORNATI AL 04/07/2017      



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