Bio Pharmaceutical Products In The Us And European Markets

Biopharmaceutical Products in the U.S. and European Markets

Biopharmaceutical Products in the U.S. and European Markets 6th edition

by Ronald A. Rader



Biopharmaceutical Products in the U.S. and European Markets

Acknowledgements The author particularly thanks his wife, Sally A. Young, for her invaluable assistance and making this book possible. Special thanks are also due to the author’s mother, Goldye Rader, for her support. The author thanks the many persons throughout the biopharmaceutical industry, FDA, and other organizations for the information and assistance they provided. ­

Title: Edition: ISBNs: Author: Publisher: Date: Web Site: History:

Biopharmaceutical Products in the U.S. and European Market 6th edition 2 volume set: 978-1-934106-04-4 (old format: 1-934106-04-6) volume 1: 978-1-934106-05-1 (1-934106-05-4) volume 2: 978-1-934106-06-8 (1-934106-06-2) Ronald A. Rader (B.S., Microbiology; M.L.S.) President, Biotechnology Information Institute (Rockville, MD) Bioplan Associates, Inc. (Rockville, MD) September 2007 (up-to-date to September 1, 2007) www.biopharma.com The 1st, 2nd and 3rd editions were entitled BIOPHARMA: Biopharmaceutical Products in the U.S. Market

Copyright © 2007 All rights reserved. This work and all of its contents are protected under U.S. and international copyright. Contact the publisher to request permission to copy or extract any text, information or data. The author and publisher cannot be held responsible for any consequences arising from any errors or omissions, nor for any consequences arising from use of the information presented. *Part of the BIOPHARMA® (registered U.S. trademark) suite of biopharmaceutical information resources

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Biopharmaceutical Products in the U.S. and European Markets

Table of Contents - Volume 1



Page 16 20 20 25 25 31 33 34 35 31 34 34 40 41 42 49 55 61 67 73 81

88 91 94 100 103

iv

Introductory, Industry Overview and Commentary Sections Users Guide Biopharmaceutical Industry – Overview and Assessments [Analysis & Comments] Overview of FDA Biopharmaceutical Approvals: 2006-August 2007 Upcoming Biopharmaceuticals: Applications Filed with FDA Products with FDA Applications Expected in 2007/8 Applications Filed in European Union Products with European Union Applications Expected in 2007/8 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?

Biopharmaceutical Products in the U.S. and European Markets

Page 110 •

Monograph Titles Entry Number Recombinant DNA Products

100

. . 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

101 102 103 104 105 106 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 139 140 141 142 143 144 145 146 147 148 149 150 151 152 153 

Biopharmaceutical Products in the U.S. and European Markets

. . . 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 vi

154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210

Biopharmaceutical Products in the U.S. and European Markets

. . . Interferon beta-1a, rDNA/Biopartners . . . 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-

210.5 211 212 213 214 215 216 217 218 219 220 221 222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 vii

Biopharmaceutical Products in the U.S. and European Markets

. . . 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

Page 710 •

267 268 269 270 271 272 273 274 275 276

Monoclonal Antibodies

300

. . . 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

301 302 303 304 305 306 307 308 309 310 311 312 313 314 315

Table of Contents - Volume 2 Page 755 • 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. viii

400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422

Biopharmaceutical Products in the U.S. and European Markets

. . . 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

423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 ix

Biopharmaceutical Products in the U.S. and European Markets

. . . . . . Influenza Vaccine/Wyeth . . . . . . 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 

480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 501 502 503 504 505 506 507 508 509 510 511 512 513 514 515 516 517 518 519 520 521 522 523 524 525 526 527 528 529 530 531 532 533 534 535 536

Biopharmaceutical Products in the U.S. and European Markets

. . . . . . 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

Page 1019 •

Toxins

Botulinum Toxin Products . . . . . . Botulinum Toxin A/Allergan . . . . . . Botulinum Toxin A/Ipsen . . . . . . Botulinum Toxin A/Merz . . . . . . Botulinum Toxin B

Page 1038 •

537 538 539 540 541 542 543 544 545 546 547 548 549 550 551 552 553 554 555 556 557 558 559 560 561 562 563 564 565 566 567

600 601 602 603 604

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

605 606 607 608 609 610 611 612 613 614 615 616 617 618 619 xi

Biopharmaceutical Products in the U.S. and European Markets

. . . Lys-Plasminogen, conc. . . . Pancreatic Enzymes . . . Papain . . . Streptokinase Products . . . Streptokinase/Astra . . . Streptokinase/Octapharma . . . Urokinase/Abbott . . . Urokinase/Microbix . . . RNase, Rana pipiens . . . Sucrase

Page 1077 •

Insulin Products

. . . Insulin, Beef/Novo . . . Insulin, Pork/Lilly . . . Insulin, Pork/Novo

Page 1086 •

650 651 652 653 654 656 657 658 659

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 xii

631 632 633

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

Page 1109 •

620 621 622 623 624 625 626 627 628 629

700 701 702 703 704 705 706 707 708 709 710 711 712 713 714 715 716 717 718 719 720 721 722 723 724 725

Biopharmaceutical Products in the U.S. and European Markets

. . . . . . 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.

726 727 728 729 730 731 732 733 734 735 736 737 738 739 740 741 742 743 744 745 746 747 748 749 750 751 752 753 754 755 756 757 758 759 760 761 762 763 764 765 766 767 768 769 770 771 772 773 774 775 776 777 778 779 780 781 782 xiii

Biopharmaceutical Products in the U.S. and European Markets

. . . . . . Staphylococcus aureus Immune Globulin . . . . . . 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

783 784 785 786 787 788 789 790 791 792 793 794 795 796 797 798 799 800 801 802 803 804 805 806 807 808 809

Page 1292 • 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

xiv

900 901 902 903 904 905 906 907 908 909 910 911 912 913 914 915 916 917 918 919 920 921 922 923

Biopharmaceutical Products in the U.S. and European Markets

Page 1324 • 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

Page



1376 1388 1402 1403

Page



1405 1409 1412 1424 1479 1531 1534 1537 1540 1542 1547 1552 1561 1572

924 925 926 927 928 929 930 931 932 933 934 935 936 937 938 939 940 941 942 943 944 945 946 947 948 949

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 xv