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Biopharmaceuticals in the US and European Markets
Bioplan Associates Inc., Sep 2007, Pages: 1,602
Introductory, Industry Overview and Commentary Sections
Users Guide
Biopharmaceutical Industry - Overview and Assessments [Analysis & Comments]
Overview of FDA Biopharmaceutical Approvals: 2006-August
Upcoming Biopharmaceuticals:
Applications Filed with FDA
Products with FDA Applications Expected in 2007/
Applications Filed in European Union
Products with European Union Applications Expected in 2007/
What's New in this 6th Edition?
Biopharmaceutical Markets - World Market Size
How Large is the US Biopharmaceutical Market?
What is a Biopharmaceutical? Part 1: (Bio)Technology-based Definitions
Blockbuster Biopharmaceuticals
Biopharmaceutical Markets and Trends by Product Class
How Large is the US Market?
Blockbuster Biopharmaceuticals - Market Analysis
Biopharmaceutical Markets and Trends by Product Class
Overview of Recombinant Expression Systems and Recombinant Protein Manufacturing Technologies
What is a Biopharmaceutical? Part 1: (Bio)Technology-Based Definitions
What is a Biopharmaceutical? Part 2: Company and Industry Definitions
What is a Generic Biopharmaceutical? Biogeneric? Follow-on Protein?
Biosimilar? Follow-on Biologic? Part 1: Introduction and Basic Paradigms
What is a Generic Biopharmaceutical? Biogeneric? Follow-on Protein?
Biosimilar? Follow-on Biologic? Part 2: Information, Nomenclature, Perceptions and the Market
Blockbusters and Major Products as Biogenerics
Overview of Corporate Involvement and Activity with Biogenerics
What Products are Candidates for Biogeneric Development
Biogenerics: Regulatory Aspects and Prospects
How Will Industry Adopt and Adapt to Biogenerics?
- Recombinant DNA Products
Albumin, rDNA
Antithrombin III, rDNA
Anthrax Vaccine, rDNA/VaxGen
Anthrax Vaccine, rDNA/Emergent
Arylsulfatase B, rDNA
Bactericidal/permeability-increasing Protein, rDNA
Bone Morphogenic Proteins
Bone Morphogenic Protein-2, rDNA
Bone Morphogenic Protein-7, rDNA
Calcitonin, rDNA
Cancer vaccine, poxvirus vectors, rDNA
Carboxypeptidase, rDNA
C1-esterase inhibitor, rDNA
CD11a Mab, rDNA
CD20 Mab, rDNA
CD20 Mab, rDNA conc
CD20 Mab, rDNA/Y-90 & In-111 radioconj
CD33 immunotoxin, rDNA
CD52 Mab, rDNA
Complement C5 Mab, rDNA
CTAA1688 Mab, rDNA-Tc 99m radioconj
Corifollitropin alfa, rDNA
CTLA4-Ig, rDNA
CTLA4 Mab, rDNA/Medarex
CTLA4 Mab, rDNA/Pfizer
DNase, rDNA
EGF, rDNA/Bharat
EGF receptor Mab, chimeric, rDNA
EGF receptor Mab, human, rDNA/Amgen
EGF receptor Mab, humanized, rDNA
EpCAM/CD3 Mab, rDNA
Erythropoietin (EPO) Products
EPO, rDNA/Amgen
EPO, rDNA/Hexal
EPO, rDNA/Medice
EPO, rDNA/Ortho
EPO, rDNA/Pliva
EPO, rDNA/Roche
EPO, rDNA/Sandoz
EPO, rDNA/Stada
EPO, rDNA/TKT
EPO, rDNA, PEG-
EPO, darb-, rDNA
Factor IX, rDNA/Wyeth
Factor VIIa, rDNA
Factor VIII:vWF, rDNA conc
Factor VIII, rDNA/Baxter
Factor VIII, rDNA, PFM
Factor VIII, rDNA/Bayer
Factor VIII, rDNA/Wyeth
Factor VIII, rDNA BHK/CSL
Factor VIII, rDNA CHO/CSL
Fibrolase, rDNA
Follicle-stimulating Hormone (FSH) Products
FSH rDNA/Schering-Plough
FSH rDNA/Merck Serono
FSH plus LH, rDNA/Merck Serono
G-CSF, rDNA/Amgen
G-CSF, rDNA, PEG-
G-CSF, rDNA/Sanofi
Galactosidase Products
Galactosidase, alfa-, rDNA
Galactosidase, beta rDNA
Glucagon, rDNA Products
Glucagon, rDNA/Lilly
Glucagon, rDNA/Novo
Glucocerebrosidase, rDNA
Glucosidase, rDNA
GM-CSF, rDNA/Berlex
GM-CSF, rDNA/Schering-Plough
GM-CSF, rDNA/Cangene
hCG, rDNA
Heat shock protein Mab Mab, rDNA
Hepatitis B Vaccine, rDNA/Merck
Hepatitis B Vaccine, rDNA/GSK
Hepatitis B Vaccine, rDNA/Medeva
Hepatitis B vaccine, rDNA/AS04
Hepatitis B vaccine, rDNA/HBVAXPRO
HER2 receptor Mab, rDNA
Hirudin Products
Hirudin, rDNA/Berlex
Hirudin, rDNA/Sanofi
Human Papillomavirus (HPV) Vaccines
HPV vaccine, rDNA/Merck
HPV vaccine, rDNA/GSK
Hyaluronidase, rDNA
Iduronidase, rDNA
Iduronate-2-sulfatase, rDNA
Immunoglobulin E Mab, rDNA
Influenza Vaccine, live rDNA, frozen
Influenza Vaccine, live rDNA, liquid
Insulin, rDNA/Lilly
Insulin, rDNA/Novo
Insulin, rDNA, inhaled/Pfizer
Insulin aspart, rDNA
Insulin detemir, rDNA
Insulin glargine, rDNA
Insulin glulisine, rDNA
Insulin lispro, rDNA
Insulin-like Growth Factor-1, rDNA/Chiron
Insulin-like Growth Factor-1, rDNA/Tercica
Insulin-like Growth Factor-1/IGFBP-3, rDNA
Integrin Mab, rDNA
Interferon alfa-2a, rDNA
Interferon alfa-2a, rDNA, PEG-
Interferon alfa-2b, rDNA
Interferon alfa, rDNA/BioPartners
Interferon alfa-2b, rDNA, PEG-
Interferon alfacon-1, rDNA
Interferon beta-1a, rDNA/Biogen
Interferon beta-1a, rDNA/Biopartners 210
Interferon beta-1a, rDNA/Merck Serono
Interferon betaser, rDNA/Berlex
Interferon gamma, rDNA
Interleukin-1ra, rDNA
Interleukin-1 trap, rDNA
Interleukin-11, rDNA
Interleukin-13-Pseudomonas toxin, rDNA
Interleukin-2, rDNA/Chiron
Interleukin-2, rDNA/Biopharma
Interleukin-2/diphtheria toxin, rDNA
Interleukin-2 receptor Mab, rDNA/Novartis
Interleukin-2 receptor Mab, rDNA/Roche
IL-6 receptor Mab, rDNA
Japanese encephalitis vaccine, rDNA/Acambis
Kallikrein inhibitor, rDNA
Keratinocyte growth factor, rDNA
LFA-3/IgG1, rDNA
Luteinizing hormone, rDNA
Lyme Vaccine, rDNA/Aventis
Lyme Vaccine, rDNA/GSK
Natriuretic peptide, rDNA
p53 Gene Therapy, rDNA/Shenzhen SiBiono
p53 Gene Therapy, rDNA/Introgen
Parathyroid hormone (1-34), rDNA
Parathyroid hormone (1-84), rDNA
Pertussis Toxoid, rDNA
PDGF, rDNA/Bone matrix
PDGF, rDNA conc
PDGF, rDNA/J&J
Platelet Mab, rDNA
Poly-4-hydroxybutyrate, rDNA
Prostate Cancer Cellular Vaccine (rDNA)
Protein C, activated, rDNA
RANKL Mab, rDNA
RSV Mab, rDNA
RSV Mab2, rDNA/MEDI-524
Somatropin (hGH) Products
Somatropin, rDNA/BioPartners
Somatropin, rDNA/Cangene
Somatropin, rDNA/Genentech
Somatropin, rDNA, depot
Somatropin, rDNA/Lilly
Somatropin, rDNA/Novo
Somatropin, rDNA/Pfizer
Somatropin, rDNA/Sandoz
Somatropin, rDNA/Ferring
Somatropin, rDNA/Merck Serono
Somatropin, rDNA met-
Somatropin antagonist, rDNA, PEG-
T4 Endonuclease, rDNA, Liposomal
Thrombin, rDNA
Thyroid stimulating hormone, rDNA
TNF, rDNA
TNF Mab, rDNA
TNF Mab, rDNA, human
TNF Mab Fab', rDNA, PEG-
TNF Receptor-IgG Fc, rDNA
tPA, rDNA/PDL
tPA, rDNA/Genentech
tPA, TNK-, rDNA
Tumor Antigen-KLH Vaccine, rDNA
Urate oxidase, rDNA
Urate oxidase, rDNA, PEG-
Urokinase Plasminogen Activator, rDNA
VEGF Mab, rDNA
VEGF Mab Fab, rDNA
- Monoclonal Antibodies
CA125 Mab
CA125 Mab F(ab')2-In111 radioconj
CD3 Mab
CEA Mab, conc
CD15 Mab-Tc 99m radioconj
CD20 Mab-I 131 radioconj
CEA Mab Fab'-Tc 99m radioconj
Granulocyte Mab-Tc99m radioconj
Melanoma Mab F(ab')2
Myosin Mab Fab radioconj
NR-LU-10 Mab Fab-Tc 99m radioconj
Prostate Mab radioconj
TAG-72 Mab, conc
TAG-72 Mab-In111 radioconj/Cytogen
TAG-72 Mab-In111 radioconj/Neoprobe
Table of Contents - Volume 2
- Vaccine Products
Adenovirus Vaccines
Adenovirus Vaccine, type 4
Adenovirus Vaccine, type 7
Anthrax Vaccine
Bacterial Antigens/Delmont
Bacterial Antigens/Mixed
BCG Vaccine Products
BCG Live/GSK
BCG Live/Sanofi
BCG Live/Schering-Plough
BCG Vaccine/Akzo
BCG Vaccine/Sanofi
Botulinum Toxoids
Cholera Vaccine/Wyeth
Cholera Vaccine (rDNA)/SBL
Dendritic Cell Vaccine, Personalized/DCVax
Dendritic Cell Vaccine, Personalized/BiovaxID
Diphtheria Toxoid Products
Diphtheria Toxoid/BioPort
Diphtheria Toxoid/Statens
Diphtheria & Tetanus Toxoids Adsorbed/Wyeth
Diphtheria & Tetanus Toxoids, conc
Diphtheria & Tetanus Toxoids/Sanofi Canada
Diphtheria & Tetanus Toxoids/Sanofi USA
Diphtheria & Tetanus Toxoids/BioPort
Diphtheria & Tetanus Toxoids/Lederle
Diphtheria & Tetanus Toxoids/Mass
DT-HBV, rDNA
Diphtheria, Tetanus and Pertussis Vaccine Products
DTaP Vaccine/Sanofi Canada
DTaP Vaccine/Sanofi USA
DTaP Vaccine/Chiron
DTaP Vaccine/GSK
DTaP Vaccine/NAVA
DTaP Vaccine/Wyeth
dTpa booster/GSK
dTpa booster/Sanofi
DTaP-HBV, rDNA
DTaP-HBV, rDNA-Hib-IPV/GSK
DTaP-HBV, rDNA-Hib-IPV/Sanofi
DTaP-HBV, rDNA-IPV/GSK
DTaP-HBV, rDNA-IPV/EU
DTaP-Hib Vaccine/Sanofi
DTaP-Hib Vaccine/Wyeth
DTaP-Hib-Polio Vaccine/Sanofi
DTaP-IPV/GSK
DTP Vaccine/Aventis
DTP Vaccine/BioPort
DTP Vaccine/Lederle
DTP Vaccine/Wyeth
DTP & Hib Vaccine/Lederle
DTP, Hib, Men A/C, HBV, rDNA vaccine
Haemophilus b Vaccine Products
Haemophilus b Vaccine (PRP-D)
Haemophilus b Vaccine (PRP-T)
Haemophilus b Vaccine/Aventis
Haemophilus b Vaccine/Lederle
Haemophilus b Vaccine/Merck
Haemophilus b Vaccine/GSK
Hib & Hepatitis B Vaccine, rDNA
Hepatitis A Vaccine Products
Hepatitis A Virus Vaccine/Berna
Hepatitis A Virus Vaccine/GSK
Hepatitis A Virus Vaccine/Merck
Hepatitis A Virus Vaccine/Sanofi
Hepatitis A & B, rDNA Vaccine
Hepatitis A & Typhoid vaccine
Hepatitis B Vaccine Products
Hepatitis B Vaccine, blood-derived
Influenza Virus Vaccine Products
Influenza Vaccine/Sanofi
Influenza Vaccine/Novartis UK
Influenza Vaccine/Novartis Germany
Influenza Vaccine/Novartis Italy
Influenza Vaccine/CSL
Influenza Vaccine/GSK Germany
Influenza vaccine/GSK Canada
Influenza Vaccine/King
Influenza Vaccine/Lederle
Influenza Vaccine, cell cultured/Novartis
Influenza vaccine, virosomal/Berna
Influenza vaccine, virosomal/Solvay
Influenza Vaccine Products, H5N1
Infleunza Vaccine, H5N1/GSK
Influenza Vaccine, H5N1/MedImmune
Influenza Vaccine, H5N1/Novartis
Influenza Vaccine, H5N1/Sanofi
Japanese Encephalitis Vaccine/Sanofi
Japanese Encephalitis Vaccine/Intercell
Measles Virus Vaccine
Measles & Mumps Virus Vaccine
Measles Mumps & Rubella Vaccine
Measles Mumps Rubella & Varicella Vaccine
Measles & Rubella Virus Vaccine/GSK
Measles & Rubella Virus Vaccine/Merck
Meningococcal Vaccines
Meningococcal Vaccine, A
Meningococcal Vaccine, A/C
Meningococcal Vaccine, C/Sanofi
Meningococcal Vaccine, C/Chiron
Meningococcal Vaccine, A/C/Y/W-135
Meningococcal Conjugates Vaccine
Mumps Virus Vaccine
Pertussis Vaccine Products
Pertussis Vaccines, Acellular
Pertussis Vaccine, acellular, conc/BIKEN
Pertussis Vaccine, acellular, conc/Takeda
Pertussis Vaccine
Pertussis Vaccine Adsorbed
Plague Vaccine
Pneumococcal Vaccines
Pneumococcal Vaccine-CRM197
Pneumococcal Vaccine/Wyeth
Pneumococcal Vaccine/Merck
Polio Vaccine Products
Poliovirus Vaccine (IPOL)
Poliovirus Vaccine (IPV)/Sanofi
Poliovirus Vaccine (IPOL)/old
Poliovirus Vaccine (IPV)/GSK
Poliovirus Vaccine, OPV
Poliovirus Vaccine, type 1
Poliovirus Vaccine, type 2
Poliovirus Vaccine, type 3
Rabies Vaccine Products
Rabies Vaccine/Sanofi Canada
Rabies Vaccine/Sanofi France
Rabies Vaccine/BioPort
Rabies Vaccine/Novartis
Rotavirus Vaccine, live/GSK
Rotavirus Vaccine, live/Merck
Rotavirus Vaccine, live/Wyeth
Rubella Virus Vaccine
Rubella & Mumps Virus Vaccine
Smallpox Vaccine Products
Smallpox Vaccine/Wyeth
Smallpox vaccine/Aventis
Smallpox Vaccine/Elstree
Smallpox vaccine/MRC-5
Smallpox vaccine/Vero
Smallpox Vaccine/MVA
Staphylococcus vaccine (rDNA)
Tetanus Toxoid Vaccines
Tetanus Toxoid/Sanofi USA
Tetanus Toxoid/Sanofi Canada
Tetanus Toxoid/Chiron
Tetanus Toxoid/Statens
Tetanus Toxoid/Wyeth
Tetanus Toxoid Adsorbed/Sanofi
Tetanus Toxoid Adsorbed/Berna
Tetanus Toxoid Adsorbed/BioPort
Tetanus Toxoid Adsorbed/Lederle
Tetanus Toxoid Adsorbed/Mass
Tetanus Toxoid Adsorbed/Wyeth
Tetanus & Diphtheria Toxoids/Sanofi
Tetanus & Diphtheria Toxoids/Sanofi Canada
Tetanus & Diphtheria Toxoids/Lederle
Tetanus & Diphtheria Toxoids/Mass
Tetanus & Diphtheria Toxoids/Wyeth
Typhoid Vaccine Products
Typhoid Vaccine/Sanofi
Typhoid Vaccine/Berna
Typhoid Vaccine/Wyeth
Varicella Virus Vaccine
Varicella Virus Vaccine/adult
Yellow Fever Vaccine/Acambis
Yellow Fever Vaccine/Sanofi
- Toxins
Botulinum Toxin Products
Botulinum Toxin A/Allergan
Botulinum Toxin A/Ipsen
Botulinum Toxin A/Merz
Botulinum Toxin B
- Enzymes
Adenosine Deaminase, PEG-
Anistreplase
Asparaginase Products
Asparaginase, E coli/OPi
Asparaginase, E coli/Ovation
Asparaginase/fungal
Asparaginase, PEG-
Collagenase
Fibrinolytic and Thrombolytic Enzymes
Fibrinolysin & DNase
Glucocerebrosidase
Hyaluronidase, bovine/Wyeth
Hyaluronidase, bovine/Amphastar
Hyaluronidase, ovine/Primapharm
Hyaluronidase, ovine/ISTA
Lys-Plasminogen, conc
Pancreatic Enzymes
Papain
Streptokinase Products
Streptokinase/Astra
Streptokinase/Octapharma
Urokinase/Abbott
Urokinase/Microbix
RNase, Rana pipiens
Sucrase
- Insulin Products
Insulin, Beef/Novo
Insulin, Pork/Lilly
Insulin, Pork/Novo
- Cultured Cells and Tissue Products
Chondrocytes, autologous
Skin, Cultured/Apligraf
Skin, Cultured/Dermagraft
Skin, Cultured/Epicel
Skin, Cultured/EpiDex
Skin, Cultured/Ortec
Skin, Cultured/TransCyte
Skin, acellular
Skin/Integra
- Blood Products, Human
Protein A/Prosorba
Stem Cell Selector
Blood, Whole and Blood Products
Albumin (Human) Products
Anti-Inhibitor Coagulant/Baxter
Anti-Inhibitor Coagulant/Nabi
Antithrombin III Products
Antithrombin III/Talacris
Antithrombin III/Octapharma
Antitrypsin, alpha-1 Products
Antitrypsin, alpha-1/Baxter
Antitrypsin, alpha-1/Talacris
Antitrypsin, alpha-1/CSL
Aprotinin
C1-esterase iIhibitor
Factor VIII Products
Factor VIII, cryoprecipitate
Factor VIII/BioPort
Factor VIII/Immuno
Factor VIII/Sanquin
Factor VIII/Talecris
Factor VIII:vWF, Mab purif/ARC
Factor VIII:vWF, Mab purif/Baxter
Factor VIII:vWF, Mab purif/CSL
Factor VIII:vWF/Talecris
Factor VIII:vWF/Grifols
Factor VIII:vWF/CSL
Factor IX Products
Factor IX Complex/Baxter
Factor IX Complex/Talecris
Factor IX Complex/Grifols
Factor IX, Mab purif/CSL
Factor IX, Mab purif/Sanquin
Factor IX SD
Factor IX VH
Fibrin Sealant Products
Fibrin sealant/OMRIX
Fibrin Sealant/Baxter
Fibrin Sealant/Haemacure
Fibrin Sealant/Thermogenesis
Hemin
Hemoglobin, polymerized
IL-1Ra, autologous
Immune Globulin Products
Anthrax immune globulin/DVC
Anthrax immune globulin/Cangene
Anthrax immune globulin/Emergent
Botulinum immune globulin
CMV Immune Globulin/CSL
CMV Immune Globulin/Biotest
CMV Immune Globulin conc
Hepatitis B Immune Globulin Products
Hepatitis B Immune Globulin/Talecris
Hepatitis B Immune Globulin/Grifols
Hepatitis B Immune Globulin, im/Nabi
Hepatitis B Immune Globulin, im/Cangene
Hepatitis B Immune Globulin, iv/Nabi
Immune Globulin (IGIM)/Mass
Immune Globulin (IGIM)/Talecris
Immune Globulin iv (IGIV) Products
Immune Globulin (IGIV-C)
Immune Globulin (IGIV)/Baxter
Immune Globulin (IGIV)/CSL
Immune Globulin (IGIV), liquid/CSL
Immune Globulin (IGIV)/Polygam
Immune Globulin (IGIV)/Talecris
Immune Globulin (IGIV)/Flebogamma
Immune Globulin (IGIV)/Venoglobulin
Immune Globulin (IGIV)/Octapharma
Immune Globulin (IGIV)/Omr-IgG-am
Immune Globulin (IGIV)/Carimune
Immune Globulin (IGIV)/Gammar-P
Immune globulin (SCIG)
Rabies Immune Globulin Products
Rabies Immune Globulin/Sanofi
Rabies Immune Globulin/Talecris
Rho(D) Immune Globulin Products
Rho(D) Immune Globulin/Talecris
Rho(D) Immune Globulin/Cangene
Rho(D) Immune Globulin/Ortho
Rho(D) Immune Globulin/CSL
RSV Immune Globulin
RSV Immune Globulin, conc
Tetanus Immune Globulin Products
Tetanus Immune Globulin/Talecris
Tetanus Immune Globulin/Grifols
Tetanus Immune Globulin/Mass
Vaccinia Immune Globulin, im
Vaccinia Immune Globulin, iv/Cangene
Vaccinia Immune Globulin, iv/DVC
Varicella-Zoster Immune Globulin/Mass
Varicella-Zoster Immune Globulin/Cangene
Interferon Products
Interferon alfa-n1
Interferon, leukocyte/HemispheRx
Interferon, leukocyte/Viragen
Leukocytes
Plasma Products
Plasma SD
Plasma Protein Fraction
Plasma, Therapeutic Exchange
Platelets
Platelets, Photoinactivated
Protein C, plasma-derived
Prothrombin Complex
Red Blood Cells
Thrombin, conc
Thrombin-Collagen Gel
Thrombin/Omrix
- Blood Products, Animal
Bovine Albumin Glue
Factor VIII, porcine
Hemoglobin glutamer, bovine
Horse Serum Products
Horse Serum/Merck
Horse Serum/Wyeth
Antivenin Products
Antivenin (Crotalidae)
Antivenin (Crotalidae) Fab
Antivenin (Latrodectus mactans)
Antivenin (Micrurus fulvius)
Botulism Antitoxin/A-G
Botulism Antitoxin/A,B,E
Digoxin Immune Globulin, ovine Fab/GSK
Digoxin Immune Globulin, ovine Fab/Protherics
Digoxin Immune Globulin, ovine Fab/Roche
Diphtheria Antitoxin
Lymphocyte Immune Globulin/Genzyme
Lymphocyte Immune Globulin/Pfizer
Thrombin Products
Thrombin/GenTrac
Thrombin/W-L
Thrombin-Collagen Gel/old
Thrombin/Collagen/Plasma
- Other Products
Collagen, human
Hyaluronic acid Products
Hyaluronic Acid/Anika
Hyaluronic acid/Ferring
Hyaluronic acid/Genzyme
Hyaluronic acid/Q-Med
Hyaluronic acid/Sanofi
Tooth Enamel Proteins
Mumps Skin Test Antigen
Enfuvirtide, synthetic
Hirudin, synthetic
Secretin, porcine, synthetic
Secretin, human, synthetic
Aluminum-based Vaccine Adjuvants
Monophosphoryl Lipid A
Thimerosal Preservative
Lung Surfactant Products
Beractant
Calfactant
Poractant alpha
Antisense Drugs
Bcl-2 Antisense Drug
CMV Antisense Drug
Poly(I)-Poly(C12U)
B-cell epitope dsDNA
VEGF apatamer, PEG
Appendices
FDA List of Approved Biologics
FDA List of Biologics Establishments
Transfer of Biologics Within FDA from CBER to CDER
Allergenic Extracts
Indexes
US State/City Index
Country Index
Marketing Territory Index
Company Role Index
Company Index
Approval Date Index
Market Size/Sales Index
Product Class Index
Regulatory/Status Index
Medical Index
Expression System/Cell Line/Source Index
Biological Index
Chemicals, Non-Active Index
Products/Active Agents Index
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