Biosimilar medicines authorized by the AEMPS

65 authorized medicines

19 active principles

Abevmy

Abevmy®

ACTIVE PRINCIPLE:
bevacizumab

INDICATION:
Colorectal cancer
Breast cancer
Ovarian cancer
Fallopian tube cancer
peritoneal cancer
Non-small cell lung carcinoma
Renal cell carcinoma
cervical cancer

DATE:
23/02/2024

STATUS:
Authorized

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Uzpruvo

Uzpruvo®

ACTIVE PRINCIPLE:
Believable

INDICATION:
plaque psoriasis
Psoriasic arthritis
Crohn's disease
Ulcerative colitis

DATE:
11/01/2024

STATUS:
Authorized

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Tyruko®

Tyruko®

ACTIVE PRINCIPLE:
natalizumab

INDICATION:
Multiple sclerosis

DATE:
29/09/2023

STATUS:
Authorized

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Tyenne®

Tyenne®

ACTIVE PRINCIPLE:
Tocilizumab
INDICATION:
Rheumatoid Arthritis
Cytokine release syndrome
Juvenile rheumatoid arthritis
COVID-19 virus infection
Giant cell arteritis
DATE:
21/09/2023
STATUS:
Authorized

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Epysqli®

Epysqli®

ACTIVE PRINCIPLE:
eculizumab
INDICATION:
paroxysmal hemoglobinuria
DATE:
20/06/2023
STATUS:
Authorized
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Bekemv®

Bekemv®

ACTIVE PRINCIPLE:
eculizumab
INDICATION:
paroxysmal hemoglobinuria
DATE:
27/04/2023
STATUS:
Authorized
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Byooviz®

Byooviz®

ACTIVE PRINCIPLE:
ranibizumab
INDICATION:
wet macular degeneration
Macular edema
Diabetic retinopathy
diabetic complications
DATE:
27/04/2023
STATUS:
Authorized
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Ximluci®

Ximluci®

ACTIVE PRINCIPLE:
ranibizumab
INDICATION:
wet macular degeneration
Macular edema
Diabetic retinopathy
diabetic complications
DATE:
22/11/2022
STATUS:
Authorized
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Vegzelma®

Vegzelma®

ACTIVE PRINCIPLE:
bevacizumab
INDICATION:
Colorectal cancer
Breast cancer
Ovarian cancer
Fallopian tube cancer
peritoneal cancer
Non-small cell lung carcinoma
Renal cell carcinoma
cervical cancer
DATE:
05/10/2022
STATUS:
Authorized

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Ranivisio®

Ranivisio®

ACTIVE PRINCIPLE:
ranibizumab
INDICATION:
wet macular degeneration
Macular edema
Diabetic retinopathy
diabetic complications
DATE:
29/09/2022
STATUS:
Authorized
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Sondelbay®

Sondelbay®

ACTIVE PRINCIPLE:
teriparatide

INDICATION:
Osteoporosis

DATE:
06/06/2022

STATUS:
Authorized

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Stimufend®

Stimufend®

ACTIVE PRINCIPLE:
Pegfilgrastim

INDICATION:
neutropenia

DATE:
17/05/2022

STATUS:
Authorized

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Hukyndra®

Hukyndra®

ACTIVE PRINCIPLE:
Adalimumab
INDICATION:
Psoriasic arthritis
Juvenile rheumatoid arthritis
Rheumatoid Arthritis
Ulcerative colitis
Crohn's disease
Hidradenitis suppurativa
Psoriasis
Ankylosing spondylitis
Uveitis
DATE:
28/12/2021
STATUS:
Authorized
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ALYMSYS®

ALYMSYS®

ACTIVE PRINCIPLE:
bevacizumab
INDICATION:
Colorectal cancer
Breast cancer
Ovarian cancer
peritoneal cancer
Non-small cell lung carcinoma
Renal cell carcinoma
cervical cancer
DATE:
28/05/2021
STATUS:
Authorized

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Oyavas®

Oyavas®

ACTIVE PRINCIPLE:
bevacizumab
INDICATION:
Colorectal cancer
Breast cancer
Ovarian cancer
Fallopian tube cancer
peritoneal cancer
Non-small cell lung carcinoma
Renal cell carcinoma
cervical cancer
DATE:
08/04/2021
STATUS:
Authorized

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Yuflyma®

Yuflyma®

ACTIVE PRINCIPLE:
Adalimumab
INDICATION:
Rheumatoid Arthritis
Juvenile rheumatoid arthritis
Psoriasis
Psoriasic arthritis
Ankylosing spondylitis
Uveitis
Ulcerative colitis
Crohn's disease
Hidradenitis suppurativa
DATE:
31/03/2021
STATUS:
Authorized
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Nyvepria®

Nyvepria®

ACTIVE PRINCIPLE:
Pegfilgrastim

INDICATION:
neutropenia

DATE:
08/01/2021

STATUS:
Authorized

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Equidacent®

Equidacent®

ACTIVE PRINCIPLE:
bevacizumab
INDICATION:
Colorectal cancer
Breast cancer
Ovarian cancer
Non-small cell lung carcinoma
Renal cell carcinoma
DATE:
29/12/2020
STATUS:
Authorized

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Livogiva®

Livogiva®

ACTIVE PRINCIPLE:
teriparatide

INDICATION:
Osteoporosis

DATE:
20/10/2020

STATUS:
Authorized

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Aybintio®

Aybintio®

ACTIVE PRINCIPLE:
bevacizumab
INDICATION:
colorectal cancer
Breast cancer
Ovarian cancer
Fallopian tube cancer
peritoneal cancer
Non-small cell lung carcinoma
Renal cell carcinoma
cervical cancer
DATE:
07/09/2020
STATUS:
Authorized
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Zercepac®

Zercepac®

ACTIVE PRINCIPLE:
trastuzumab
INDICATION:
Breast cancer
Stomach cancer
DATE:
03/08/2020
STATUS:
Authorized
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Ruxience®

Ruxience®

ACTIVE PRINCIPLE:
Rituximab

INDICATION:
B-cell chronic lymphocytic leukemia
Rheumatoid Arthritis
microscopic polyangiitis
Pemphigus

DATE:
26/04/2020

STATUS:
Authorized

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Fulphila®

Fulphila®

ACTIVE PRINCIPLE:
pegfilgrastim

INDICATION:
neutropenia

DATE:
25/10/2019

STATUS:
Authorized

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Zirabev®

Zirabev®

ACTIVE PRINCIPLE:
bevacizumab

INDICATION:
Colon or rectal carcinoma
Breast cancer
Non-small cell lung cancer
renal cell cancer
Cervical cancer

DATE:
30/09/2019

STATUS:
Authorized

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Mvasi®

Mvasi®

ACTIVE PRINCIPLE:
Bevacizumab

INDICATION:
Colon or rectal carcinoma
Breast cancer
Non-small cell lung cancer
renal cell cancer
Ovarian, fallopian tube and peritoneal cancer
Cervical cancer

DATE:
27/09/2019

STATUS:
Authorized

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Enoxaparin Ledraxen®

Enoxaparin Ledraxen®

ACTIVE PRINCIPLE:
Enoxaparin Sodium

INDICATION:
venous thrombosis

DATE:
08/08/2019

STATUS:
Authorized

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Idacio®

Idacio®

ACTIVE PRINCIPLE:
adalimumab

INDICATION:
Rheumatoid Arthritis
Juvenile rheumatoid arthritis
Psoriasic arthritis
Ulcerative colitis
Crohn's disease
Psoriasis
Ankylosing spondylitis
Hidradenitis suppurativa
Uveitis

DATE:
08/07/2019

STATUS:
Authorized

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ENOXAPARIN GINELADIUS®

ENOXAPARIN GINELADIUS®

ACTIVE PRINCIPLE:
Enoxaparin Sodium

INDICATION:
venous thrombosis

DATE:
23/05/2019

STATUS:
Authorized

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Ogivri®

Ogivri®

ACTIVE PRINCIPLE:
trastuzumab

INDICATION:
Breast cancer
Stomach cancer

DATE:
28/02/2019

STATUS:
Authorized

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Semglee®

Semglee®

ACTIVE PRINCIPLE:
Insulin glargine

INDICATION:
Diabetes mellitus type 2

DATE:
25/02/2019

STATUS:
Authorized

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Ziextenzo®

Ziextenzo®

ACTIVE PRINCIPLE:
Pegfilgrastim

INDICATION:
neutropenia

DATE:
08/02/2019

STATUS:
Authorized

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Earthy®

Earthy®

ACTIVE PRINCIPLE:
teriparatide

INDICATION:
Osteoporosis

DATE:
31/01/2019

STATUS:
Authorized

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PELMEG®

PELMEG®

ACTIVE PRINCIPLE:
Pegfilgrastim

INDICATION:
neutropenia

DATE:
12/12/2018

STATUS:
Authorized

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Trazimera®

Trazimera®

ACTIVE PRINCIPLE:
Trastuzumab

INDICATION:
breast and stomach cancer

DATE:
30/11/2018

STATUS:
Authorized

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Hulio®

Hulio®

ACTIVE PRINCIPLE:
adalimumab

INDICATION:
Ankylosing spondylitis
uveitis
Rheumatoid Arthritis
Hidradenitis suppurativa
Ulcerative colitis
Psoriasic arthritis
Crohn's disease
Psoriasis

DATE:
15/11/2018

STATUS:
Authorized

MORE INFORMATION

Pelgraz®

Pelgraz®

ACTIVE PRINCIPLE:
Pegfilgrastim

INDICATION:
neutropenia

DATE:
31/10/2018

STATUS:
Authorized

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HEPAXANE®

HEPAXANE®

ACTIVE PRINCIPLE:
Enoxaparin Sodium

INDICATION:
venous thrombosis

DATE:
27/09/2018

STATUS:
Authorized

MORE INFORMATION

Hyrimoz®

Hyrimoz®

ACTIVE PRINCIPLE:
adalimumab

INDICATION:
Ankylosing spondylitis
uveitis
Rheumatoid Arthritis
Hidradenitis suppurativa
Ulcerative colitis
Psoriasic arthritis
Crohn's disease
papulosquamous diseases
Juvenile rheumatoid arthritis

DATE:
16/08/2018

STATUS:
Authorized

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Movymia®

Movymia®

ACTIVE PRINCIPLE:
teriparatide

INDICATION:
Osteoporosis

DATE:
01/08/2018

STATUS:
Authorized

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Zessly®

Zessly®

ACTIVE PRINCIPLE:
Infliximab

INDICATION:
Ankylosing spondylitis
Rheumatoid arthritis
Ulcerative colitis
Psoriasic arthritis
Crohn's disease
Psoriasis

DATE:
16/07/2018

STATUS:
Authorized

MORE INFORMATION

Kanjinti®

Kanjinti®

ACTIVE PRINCIPLE:
Trastuzumab

INDICATION:
Breast cancer
Stomach cancer

DATE:
28/05/2018

STATUS:
Authorized

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Imraldi®

Imraldi®

ACTIVE PRINCIPLE:
adalimumab

INDICATION:
Ankylosing spondylitis
Arthritis
Uveitis
Rheumatoid Arthritis
Hidradenitis suppurativa
Ulcerative colitis
Psoriasic arthritis
Crohn's disease
Psoriasis

DATE:
25/05/2018

STATUS:
Authorized

MORE INFORMATION

Amgevita®

Amgevita®

ACTIVE PRINCIPLE:
Adalimumab

INDICATION:
Rheumatoid Arthritis
Juvenile idiopathic arthritis
axial spondylitis
Psoriasic arthritis
Psoriasis
Pediatric plaque psoriasis
Hidradenitis suppurativa
Crohn's disease
Pediatric Crohn's disease
Ulcerative colitis
Uveitis
pediatric uveitis

DATE:
13/04/2018

STATUS:
Authorized

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Ontruzant®

Ontruzant®

ACTIVE PRINCIPLE:
Trastuzumab

INDICATION:
Breast cancer
Stomach cancer

DATE:
13/04/2018

STATUS:
Authorized

MORE INFORMATION

Herzuma®

Herzuma®

ACTIVE PRINCIPLE:
Trastuzumab

INDICATION:
Breast cancer
Stomach cancer

DATE:
16/03/2018

STATUS:
Authorized

MORE INFORMATION

inhixa®

inhixa®

ACTIVE PRINCIPLE:
Enoxaparin Sodium

INDICATION:
venous thrombosis

DATE:
16/03/2018

STATUS:
Authorized

MORE INFORMATION

ENOXAPARIN ROVI®

ENOXAPARIN ROVI®

ACTIVE PRINCIPLE:
Enoxaparin Sodium

INDICATION:
venous thrombosis

DATE:
27/02/2018

STATUS:
Authorized

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CRUSIA®

CRUSIA®

ACTIVE PRINCIPLE:
Enoxaparin Sodium

INDICATION:
venous thrombosis

DATE:
20/02/2018

STATUS:
Authorized

MORE INFORMATION

Rixathon®

Rixathon®

ACTIVE PRINCIPLE:
rituximab

INDICATION:
Wegener's granulomatosis
microscopic polyangiitis
Rheumatoid Arthritis
Non-Hodgkin lymphoma
B-cell chronic lymphocytic leukemia

DATE:
31/07/2017

STATUS:
Authorized

MORE INFORMATION

Erelzi®

Erelzi®

ACTIVE PRINCIPLE:
etanercept

INDICATION:
Psoriasic arthritis
Psoriasis
Juvenile rheumatoid arthritis
Rheumatoid Arthritis
Ankylosing spondylitis

DATE:
26/07/2017

STATUS:
Authorized

MORE INFORMATION

Riximyo®

Riximyo®

ACTIVE PRINCIPLE:
rituximab

INDICATION:
Wegener's granulomatosis
microscopic polyangiitis
Rheumatoid Arthritis
Non-Hodgkin lymphoma

DATE:
26/07/2017

STATUS:
Authorized

MORE INFORMATION

Truxima®

Truxima®

ACTIVE PRINCIPLE:
Rituximab

INDICATION:
Rheumatoid Arthritis
Non-Hodgkins lymphoma
Chronic lymphocytic leukemia
Granulomatosis with polyangiitis
microscopic polyangiitis

DATE:
07/04/2017

STATUS:
Authorized

MORE INFORMATION

Flixabi®

Flixabi®

ACTIVE PRINCIPLE:
Infliximab

INDICATION:
Psoriasic arthritis
Rheumatoid Arthritis
Psoriasis
Ulcerative colitis
Crohn's disease
Ankylosing spondylitis

DATE:
07/07/2016

STATUS:
Authorized

MORE INFORMATION

Abasaglar® (formerly Abasria®)

Abasaglar® (formerly Abasria®)

ACTIVE PRINCIPLE:
Insulin glargine

INDICATION:
Diabetes Mellitus

DATE:
23/06/2016

STATUS:
Authorized

MORE INFORMATION

Benepali®

Benepali®

ACTIVE PRINCIPLE:
etanercept

INDICATION:
Psoriasic arthritis
Rheumatoid Arthritis
plaque psoriasis
Ankylosing spondylitis

DATE:
25/02/2016

STATUS:
Authorized

MORE INFORMATION

Ovaleap®

Ovaleap®

ACTIVE PRINCIPLE:
follitropin alfa

INDICATION:
Anovulation

DATE:
16/02/2015

STATUS:
Authorized

MORE INFORMATION

Accofil®

Accofil®

ACTIVE PRINCIPLE:
filgrastim

INDICATION:
neutropenia

DATE:
10/10/2014

STATUS:
Authorized

MORE INFORMATION

Bemfola®

Bemfola®

ACTIVE PRINCIPLE:
follitropin alfa

INDICATION:
Anovulation

DATE:
23/06/2014

STATUS:
Authorized

MORE INFORMATION

Remsima®

Remsima®

ACTIVE PRINCIPLE:
Infliximab

INDICATION:
Rheumatoid Arthritis
Crohn's disease
Ulcerative colitis
Ankylosing spondylitis
Psoriasic arthritis
Psoriasis

DATE:
23/06/2014

STATUS:
Authorized

MORE INFORMATION

Inflectra®

Inflectra®

ACTIVE PRINCIPLE:
Infliximab

INDICATION:
Rheumatoid Arthritis
Crohn's disease
Ulcerative colitis
Ankylosing spondylitis
Psoriasic arthritis
Psoriasis

DATE:
25/03/2014

STATUS:
Authorized

MORE INFORMATION

Nivestim®

Nivestim®

ACTIVE PRINCIPLE:
Filgastrim

INDICATION:
Neutropenia in the context of oncological processes
Hematopoietic stem cell transplantation

DATE:
19/10/2010

STATUS:
Authorized

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Tevagastrim®

Tevagastrim®

ACTIVE PRINCIPLE:
Filgastrim

INDICATION:
Neutropenia in the context of oncological processes
Hematopoietic stem cell transplantation

DATE:
07/12/2009

STATUS:
Authorized

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Zarzio®

Zarzio®

ACTIVE PRINCIPLE:
Filgastrim

INDICATION:
Neutropenia in the context of oncological processes
Hematopoietic stem cell transplantation

DATE:
31/03/2009

STATUS:
Authorized

MORE INFORMATION

Ratiogastrim®

Ratiogastrim®

ACTIVE PRINCIPLE:
Filgastrim

INDICATION:
Neutropenia in the context of oncological processes
Hematopoietic stem cell transplantation

DATE:
25/09/2008

STATUS:
Authorized

MORE INFORMATION

Retacrit®

Retacrit®

ACTIVE PRINCIPLE:
Epoetin Zeta

INDICATION:
Anemia secondary to oncological processes
end-stage renal failure

DATE:
27/02/2008

STATUS:
Authorized

MORE INFORMATION

Binocrit®

Binocrit®

ACTIVE PRINCIPLE:
epoetin alfa

INDICATION:
Anemia secondary to oncological processes
end-stage renal failure

DATE:
18/02/2008

STATUS:
Authorized

MORE INFORMATION

Omnitrope®

Omnitrope®

ACTIVE PRINCIPLE:
Somatotropin

INDICATION:
Dwarfism
Prader-Willi syndrome
Turner syndrome

DATE:
06/07/2006

STATUS:
Authorized

MORE INFORMATION

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