Manufacturer of drug substance

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1 Original s and Biosimilars (marketing authorizations in the EU) Date: January ) Somatropin s ORIGINAL PRODUCTS: Authorization Genentech Genotropin Somatropin Pharmacia/ Pfizer E. coli Humatrope Somatropin Lilly Lilly E. coli Norditropin Somatropin Novo Nordisk Novo Nordisk E. coli Nutropinaq Somatropin Ipsen Genentech E. coli Somatropin Biopartners Somatropin BioPartners LG Life Sciences Saccharomyces cerevisiae Saizen Somatropin Merck Serono Merck Serono Mouse cells C127 Zomacton Somatropin Ferring Ferring E. coli Omnitrope Somatropin Sandoz Sandoz E. coli Genotropin, Somatropin

2 2) Filgrastim s ORIGINAL PRODUCTS: Neupogen Filgrastim Amgen Amgen E. coli Granocyte Lenograstim Chugai Pharma Chugai Pharma CHO cells Lonquex Lipegfilgrastim Teva Merckle Biotec E. coli Neulasta Pegfilgrastim Amgen Amgen E. coli Ristempa Pegfilgrastim Amgen Amgen E. coli 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: INN (Name of Filgrastim Filgrastim Hexal Sandoz E. coli Neupogen, Filgrastim Hexal Zarzio Filgrastim Sandoz Sandoz E. coli Neupogen, Filgrastim Ratiograstim Filgrastim ratiopharm SICOR Biotech E. coli Neupogen, Filgrastim Tevagrastim Filgrastim Teva SICOR Biotech E. coli Neupogen, Filgrastim Nivestim Filgrastim Hospira Hospira E. coli Neupogen, Filgrastim Grastofil Filgrastim Apotex Intas Pharmaceuticals E. coli Neupogen, Filgrastim Accofil Filgrastim Apotex Intas Pharmaceutical E. coli 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 3) Epoetin s ORIGINAL PRODUCTS: Aranesp Darbepoetin alfa Amgen Amgen CHO cells Erypo Epoetin alfa Janssen-Cilag Johnson & CHO cells Johnson Neorecormon Epoetin beta Roche Roche CHO cells Mircera Methoxy-Poly- Roche Roche CHO cells ethylen-glycol- Epoetin beta Biopoin Epoetin theta Teva Merckle Biotec CHO cells Eporatio Epoetin theta Ratiopharm Merckle Biotec CHO cells 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: Abseamed Epoetin alfa medice Lek; Rentschler CHO cells Erypo, Epoetin alfa Epoetin alfa Epoetin alfa Hexal Lek; Rentschler CHO cells Erypo, Epoetin alfa Hexal Binocrit Epoetin alfa Sandoz Lek; Rentschler CHO cells Erypo, Epoetin alfa Retacrit Epoetin zeta Hospira Norbitec CHO cells Erypo, Epoetin alfa Silapo Epoetin zeta Stada Norbitec CHO cells Erypo, Epoetin alfa 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 4) Follitropin alfa s ORIGINAL PRODUCT: of drug Gonal-f Follitropin alfa Merck Serono Merck Serono CHO cells BIOSIMILARS: Ovaleap Follitropin alfa Teva Merckle Biotec CHO cells Gonal-f, Follitropin alfa Bemfola Follitropin alfa Finox Biotech Polymun Scientific Immunbiologische Forschung CHO cells Gonal-f, Follitropin alfa Seite 4/7

5 5) Monoclonal Antibodies ORIGINAL PRODUCT: Remicade Infliximab Janssen Biologics of drug Janssen Biologics Mouse cells Inflectra Infliximab Hospira Celltrion Mouse cells Remicade, Infliximab Remsima Infliximab Celltrion Celltrion Mouse cells 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 6) Insulin glargine s ORIGINAL PRODUCT: of drug Lantus Insulin glargine Sanofi-Aventis Sanofi-Aventis E. coli of drug Abasaglar Insulin glargine Eli Lilly Lilly del Caribe, Eli Lilly and Company E. coli Lantus, Insulin glargin Seite 6/7

7 7) Fusion proteins ORIGINALPRÄPARAT: Enbrel Etanercept Pfizer Boehringer Ingelheim Pharma, Pfizer Ireland Pharmaceuticals CHO cells of drug Benepali Etanercept Samsung Bioepis Biogen Idec CHO cells Enbrel, Etanercept Seite 7/7