Original Products and Biosimilars (marketing authorizations in

Original Products and Biosimilars (marketing authorizations in the EU)
Date: January 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.
Seite 2/7
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 (orange) 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.
Seite 3/7
4) Follitropin alfa Products
ORIGINAL PRODUCT:
Product
INN (Name of
drug substance)
Gonal-f
Follitropin alfa
Marketing
Authorisation
Holder
Merck Serono
Manufacturer of
drug substance
Cell line
Merck Serono
CHO cells
CHO = Chinese Hamster Ovary
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
Cell line
CHO cells
CHO cells
Reference product, INN
Gonal-f, Follitropin alfa
Gonal-f, Follitropin alfa
CHO = Chinese Hamster Ovary
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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
INN (Name of
drug substance)
Infliximab
Infliximab
Marketing
Authorisation
Holder
Hospira
Celltrion
Manufacturer
of drug
substance
Celltrion
Celltrion
Cell line
Reference product, INN
Mouse cells
Mouse cells
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.
Seite 5/7
6) 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
Seite 6/7
7) Fusion proteins
ORIGINALPRÄPARAT:
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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