1) Somatropin Products

Original Products and Biosimilars (marketing authorizations in the EU)
Date: December 2016
1) Somatropin Products
ORIGINAL PRODUCTS:
Product
INN (Name of
drug substance)
Genotropin
Somatropin
Humatrope
Norditropin
Nutropinaq
Somatropin
Biopartners
Saizen
Zomacton
Somatropin
Somatropin
Somatropin
Somatropin
Marketing Authorization
Holder
Pharmacia/
Pfizer
Lilly
Novo Nordisk
Ipsen
BioPartners
Manufacturer
of drug substance
Genentech
Cell line
Lilly
Novo Nordisk
Genentech
LG Life Sciences
E. coli
E. coli
E. coli
Saccharomyces
cerevisiae
Mouse cells C127
E. coli
Somatropin
Somatropin
Merck Serono
Ferring
Merck Serono
Ferring
Marketing Authorisation
Holder
Sandoz
Manufacturer
of drug substance
Sandoz
E. coli
BIOSIMILAR:
Product
Omnitrope
INN (Name of
drug substance)
Somatropin
Cell line
Reference product, INN
E. coli
Genotropin, Somatropin
2) Filgrastim Products
ORIGINAL PRODUCTS:
Product
Neupogen
Granocyte
Lonquex
Neulasta
Ristempa
INN (Name of
drug substance)
Filgrastim
Lenograstim
Lipegfilgrastim
Pegfilgrastim
Pegfilgrastim
Marketing Authorisation
Holder
Amgen
Chugai Pharma
Teva
Amgen
Amgen
Manufacturer
of drug substance
Amgen
Chugai Pharma
Merckle Biotec
Amgen
Amgen
Cell line
E. coli
CHO cells
E. coli
E. coli
E. coli
CHO = Chinese Hamster Ovary
The two products of Amgen (grey) are one product with two brand names, they are produced in one and the same
manufacturing plant, are identical among each other and substitutable among each other.
BIOSIMILARS:
Product
Filgrastim Hexal
Zarzio
Ratiograstim
Tevagrastim
Nivestim
Grastofil
Accofil
INN (Name
ofdrug substance)
Filgrastim
Marketing Authorisation
Holder
Hexal
Manufacturer
of drug substance
Sandoz
Filgrastim
Filgrastim
Filgrastim
Filgrastim
Filgrastim
Sandoz
ratiopharm
Teva
Hospira
Apotex
Filgrastim
Apotex
Sandoz
SICOR Biotech
SICOR Biotech
Hospira
Intas Pharmaceuticals
Intas Pharmaceutical
Cell line
Reference product, INN
E. coli
Neupogen, Filgrastim
E.
E.
E.
E.
E.
Neupogen,
Neupogen,
Neupogen,
Neupogen,
Neupogen,
coli
coli
coli
coli
coli
E. coli
Filgrastim
Filgrastim
Filgrastim
Filgrastim
Filgrastim
Neupogen, Filgrastim
The products of Hexal and Sandoz are one biosimlar with two brand names (red); the products of Ratiopharm and
Teva with three brand names (blue) are one biosimilar as this is the case for the products of Intas Pharmaceuticals
(orange). Biosimilars with several brand names are produced in one and the same manufacturing plant of the generic
producer, are therefore identical among each other and substitutable among each other.
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3) Epoetin Products
ORIGINAL PRODUCTS:
Product
INN (Name of
drug substance)
Aranesp
Erypo
Darbepoetin alfa
Epoetin alfa
Neorecormon
Mircera
Epoetin beta
Methoxy-Polyethylen-glycolEpoetin beta
Epoetin theta
Epoetin theta
Biopoin
Eporatio
Marketing Authorisation
Holder
Amgen
Janssen-Cilag
Cell line
Roche
Roche
Manufacturer
of drug substance
Amgen
Johnson &
Johnson
Roche
Roche
Teva
Ratiopharm
Merckle Biotec
Merckle Biotec
CHO cells
CHO cells
CHO cells
CHO cells
CHO cells
CHO cells
CHO = Chinese Hamster Ovary
The products of Teva and ratiopharm (grey) are one product with two brand names, they are produced in one and
the same manufacturing plant, are identical among each other and substitutable among each other.
BIOSIMILARS:
Product
Abseamed
Epoetin alfa
Hexal
Binocrit
Retacrit
Silapo
INN (Name of
drug substance)
Epoetin alfa
Epoetin alfa
Marketing Authorisation
Holder
medice
Hexal
Manufacturer
of drug substance
Lek; Rentschler
Lek; Rentschler
Epoetin alfa
Epoetin zeta
Epoetin zeta
Sandoz
Hospira
Stada
Lek; Rentschler
Norbitec
Norbitec
Cell line
Reference product, INN
CHO cells
CHO cells
Erypo, Epoetin alfa
Erypo, Epoetin alfa
CHO cells
CHO cells
CHO cells
Erypo, Epoetin alfa
Erypo, Epoetin alfa
Erypo, Epoetin alfa
CHO = Chinese Hamster Ovary
The products of medice, Hexal and Sandoz are one biosimilar with three brand names (red); die products of Hospira
and Stada are one biosimilar with two brand names (blue). Biosimilars with several brand names are produced in one
and the same manufacturing plant of the generic producer, are therefore identically among each other and substitutable among each other.
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4) Follitropin alfa Products
ORIGINAL PRODUCT:
Product
INN (Name of
drug substance)
Gonal-f
Fertavid
Puregon
Elonva
Pergoveris
Follitropin alfa
Follitropin beta
Follitropin beta
Corifollitropin
Follitropin alfa/
Lutropin alfa
Marketing Authorisation
Holder
Merck Serono
Organon
Organon
Organon
Merck Serono
Manufacturer of
drug substance
Cell line
Merck Serono
Organon
Organon
Organon
Merck Serono
CHO
CHO
CHO
CHO
CHO
cells
cells
cells
cells
cells
CHO = Chinese Hamster Ovary
The two products of Organon (grey) are one product with two brand names, they are produced in one and the same
manufacturing plant, are identical among each other and substitutable among each other.
BIOSIMILARS:
Product
INN (Name of
drug substance)
Ovaleap
Bemfola
Follitropin alfa
Follitropin alfa
Marketing Authorisation
Holder
Teva
Finox Biotech
Manufacturer
of drug substance
Merckle Biotec
Polymun Scientific Immunbiologische Forschung
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Cell line
CHO cells
CHO cells
Reference product, INN
Gonal-f, Follitropin alfa
Gonal-f, Follitropin alfa
CHO = Chinese Hamster Ovary
5) Monoclonal Antibodies
ORIGINAL PRODUCT:
Product
Remicade
INN (Name of
drug substance)
Infliximab
Marketing Authorisation
Holder
Janssen Biologics
Manufacturer of
drug substance
Cell line
Janssen Biologics
Mouse cells
BIOSIMILAR:
Product
Inflectra
Remsima
Flixabi
INN (Name of
drug substance)
Infliximab
Infliximab
Infliximab
Marketing Authorisation
Holder
Hospira
Celltrion
Samsung Bioepsis
Manufacturer
of drug substance
Celltrion
Celltrion
Biogen
Cell line
Reference product, INN
Mouse cells
Mouse cells
CHO cells
Remicade, Infliximab
Remicade, Infliximab
Remicade, Infliximab
The products of Hospira and Celltrion (red) are one product with two brand names, they are produced in one and the
same manufacturing plant, are identical among each other and substitutable among each other.
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6) Fusion Proteins
ORIGINAL PRODUCT:
Product
Enbrel
INN (Name of
drug substance)
Etanercept
Marketing Authorisation Holder
Pfizer
Manufacturer of drug substance
Boehringer Ingelheim Pharma,
Pfizer Ireland Pharmaceuticals
Cell line
CHO cells
BIOSIMILAR:
Product
INN (Name of
drug substance)
Benepali
Etanercept
Marketing Authorisation
Holder
Samsung Bioepis
Manufacturer of
drug substance
Cell line
Reference product, INN
Biogen Idec
CHO cells
Enbrel, Etanercept
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7) Insulin Glargine Products
ORIGINAL PRODUCT:
Product
INN (Name of
drug substance)
Lantus
Insulin glargine
Marketing Authorisation Holder
Sanofi-Aventis
Manufacturer of
drug substance
Cell line
Sanofi-Aventis
E. coli
BIOSIMILAR:
Product
INN (Name of
drug substance)
Abasaglar
Insulin glargine
Marketing Authorisation
Holder
Eli Lilly
Manufacturer of
drug substance
Cell line
Reference product, INN
Lilly del Caribe, Eli
Lilly and Company
E. coli
Lantus, Insulin glargin
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8) Enoxaparin-Produkte (low molecular weight heparins)
ORIGINALPRÄPARAT:
Product
Clexane
INN (Name of
drug substance)
Enoxaparin sodium
Marketing Authorisation Holder
Sanofi-Aventis
Manufacturer of
drug substance
Sanofi-Aventis
Produced
from
Porcine intestinal mucosa
BIOSIMILAR:
Product
INN (Name of
drug substance)
Inhixa
Enoxaparin sodium
Thorinane
Enoxaparin sodium
Marketing Authorisation
Holder
Techdow Europe
AB
Pharmathen S.A.
Manufacturer of
drug substance
Produced
from
Reference product, INN
Shenzhen Techdow Pharmaceutical Co
Shenzhen Techdow Pharmaceutical Co
Porcine intestinal mucosa
Clexane, Enoxaparin sodium
Porcine intestinal mucosa
Clexane, Enoxaparin sodium
The products of Techdow und Pharmathen (red) are one product with two brand names, they are produced in one
and the same manufacturing plant, are identical among each other and substitutable among each other.
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