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. Seite 2/8 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. Seite 3/8 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 Seite 4/8 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. Seite 5/8 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 Seite 6/8 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 Seite 7/8 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. Seite 8/8
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