Biopharmaceutical Products In US And European Markets

Published by: BioPlan Associates, Inc.

Published: Sep. 1, 2007 - 1602 Pages

Table of Contents

Table of Contents - Volume 1

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 U.S 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 U.S. 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

. . . CTAA16.88 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, i.m./Nabi

. . . . . . Hepatitis B Immune Globulin, i.m./Cangene

. . . . . . Hepatitis B Immune Globulin, i.v./Nabi

. . . . . . Immune Globulin (IGIM)/Mass.

. . . . . . Immune Globulin (IGIM)/Talecris

. . . . . . Immune Globulin i.v. (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, i.m.

. . . . . . Vaccinia Immune Globulin, i.v./Cangene

. . . . . . Vaccinia Immune Globulin, i.v./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

U.S. 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

Abstract

• Bigger - 1,602 pages, 2 bound volumes; Over 50 new entries
• Newer - Includes upcoming products in 2008, with reviews and analysis, including biogenerics
• Broader - Over 500 monographs with more European, biodefense and biogenerics coverage
• Better - 6th generation reference resource
• Up-to-date - Mid-September 2007
• Bonus Sections - More reviews and analyses of products, FDA approvals and biogenerics (follow-on proteins, biosimilars, and defense products.)

• Includes all biopharmaceuticals - recombinant and other proteins, monoclonal antibodies, vaccines, enzymes, blood products, radioimmune conjugates, cultured cells and tissues
• More than a directory - Besides detailed descriptions and indexing, includes competitive, technological and regulatory intelligence; much unique and hard-to-find information.
• Free Product and Company Web databases to locate monographs in the book
• Full text Web database subscriptions available

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