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PDA Biosimilars Workshop Report (September 27—28, 2018)—Getting It Right the First Time for Biosimilar Marketing Applications

Stephan Krause, Emanuela Lacana, Joel Welch, Marjorie Shapiro, Christopher Downey, Jee Chung, Qing Zhou, Martijn Van Der Plas, Chantal Depatie, Bev Ingram, Catherine Srebalus-Barnes, Alla Polozova, Barbara Rellahan, Daeseok Choi, Richard Burdick, Thomas Stangler and Emily Shacter
PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 401-416; DOI: https://doi.org/10.5731/pdajpst.2019.010215

Article Information

vol. 73 no. 4 401-416
DOI 
https://doi.org/10.5731/pdajpst.2019.010215
PubMed 
31004040
Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online August 6, 2019.

Article Versions

Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Stephan Krause1,*,
  2. Emanuela Lacana2,
  3. Joel Welch2,
  4. Marjorie Shapiro2,
  5. Christopher Downey2,
  6. Jee Chung2,
  7. Qing Zhou2,
  8. Martijn Van Der Plas3,
  9. Chantal Depatie4,
  10. Bev Ingram5,
  11. Catherine Srebalus-Barnes6,
  12. Alla Polozova7,
  13. Barbara Rellahan8,
  14. Daeseok Choi9,
  15. Richard Burdick10,
  16. Thomas Stangler11 and
  17. Emily Shacter12
  1. 1AstraZeneca Biologics, 1 Medimmune Way, Gaithersburg, MD 20878;
  2. 2CDER, U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, Silver Spring, MD 20993;
  3. 3Medicines Evaluation Board (MEB), Graadt van Roggenweg 500, 3531 AH Utrecht, The Netherlands;
  4. 4Health Canada, 100 Eglantine Driveway, Ottawa, ON K1A 0K9, Canada;
  5. 5Pfizer Inc., 1 Burtt Road, Andover, MA 01810;
  6. 6Pfizer Inc., 275 North Field Drive, Lake Forest, IL 60045;
  7. 7Amgen Inc., 360 Binney Street, Cambridge, MA 02142;
  8. 8Amgen, Inc., 601 13th Street, NW, Suite 1100 North, Washington, DC 20005;
  9. 9CELLTRION Inc., 19, Academy-ro 51, Yeonsu-gu, Incheon 406-840, Republic of Korea;
  10. 10Burdick Statistical Consulting, LLC, 7783 Renegade Hill Drive, Colorado Springs, CO 80923;
  11. 11Novartis, Biochemiestraße 10, 6336 Langkampfen, Austria; and
  12. 12ThinkFDA, LLC, 710 Erie Ave, Takoma Park, MD 20912
  1. ↵* Corresponding Author: AstraZeneca Biologics, 1 Medimmune Way, Gaithersburg, MD 20878; Phone: 301-398-2108; E-mail: Stephan.Krause{at}astrazeneca.com
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PDA Biosimilars Workshop Report (September 27—28, 2018)—Getting It Right the First Time for Biosimilar Marketing Applications
Stephan Krause, Emanuela Lacana, Joel Welch, Marjorie Shapiro, Christopher Downey, Jee Chung, Qing Zhou, Martijn Van Der Plas, Chantal Depatie, Bev Ingram, Catherine Srebalus-Barnes, Alla Polozova, Barbara Rellahan, Daeseok Choi, Richard Burdick, Thomas Stangler, Emily Shacter
PDA Journal of Pharmaceutical Science and Technology Jul 2019, 73 (4) 401-416; DOI: 10.5731/pdajpst.2019.010215
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