Table 1

Biosimilars marketed in the EU

Product ClassReference products Approved Therapeutic Indications of the Reference ProductBiosimilarsApproved Therapeutic Indications of the Biosimilar
Epoetins epoetin-alfa
(Eprex®, Erypo®)
Anaemia, Cancer, CRF, ABT HX575 (epoetin alfa)
Abseamed®, Epoetin Alfa Hexal®
Binocrit®
Anaemia, Cancer, CRF

Anaemia, CRF
SB-309 (epoetin zeta)
(Retacrit®, Silapo®)

Anaemia, Cancer, CRF, ABT
G-CSFs filgrastim
(Neupogen®)
Neutropenia, Cancer, HSCT XM02
(Biograstim®, Ratiograstim®, Tevagrastim®)

Neutropenia, Cancer, HSCT
EP2006
(Zarzio®, Filgrastim Hexal®)

Neutropenia, Cancer, HSCT
PLD108
(Nivestim®)

Neutropenia, Cancer, HSCT
Human Growth Hormones somatropin
(Genotropin®, Humatrope®)

Growth hormone deficiency
Small for gestational age
Prader-Willi syndrome
Turner syndrome
Idiopathic short stature
EP 2000
(Omnitrope®)

Growth hormone deficiency
Growth retardation due to CKF
Small for gestational age
Prader-Willi syndrome
Turner syndrome
  • CRF: Chronic Renal Failure, ABT: Autologous Blood Transfusion, HSCT: Haematopoietic Stem Cell Transplantation.

  • NB: epoetin theta (Ratioepo®, Biopoin®) was developed and licensed as a stand-alone product and is not technically considered as a biosimilar by EMA.3