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Research ArticleConference Proceedings

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
Stephan Krause
1AstraZeneca Biologics, 1 Medimmune Way, Gaithersburg, MD 20878;
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  • For correspondence: Stephan.Krause@astrazeneca.com
Emanuela Lacana
2CDER, U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, Silver Spring, MD 20993;
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Joel Welch
2CDER, U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, Silver Spring, MD 20993;
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Marjorie Shapiro
2CDER, U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, Silver Spring, MD 20993;
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Christopher Downey
2CDER, U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, Silver Spring, MD 20993;
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Jee Chung
2CDER, U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, Silver Spring, MD 20993;
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Qing Zhou
2CDER, U.S. Food and Drug Administration (FDA), 10903 New Hampshire Ave, Silver Spring, MD 20993;
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Martijn Van Der Plas
3Medicines Evaluation Board (MEB), Graadt van Roggenweg 500, 3531 AH Utrecht, The Netherlands;
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Chantal Depatie
4Health Canada, 100 Eglantine Driveway, Ottawa, ON K1A 0K9, Canada;
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Bev Ingram
5Pfizer Inc., 1 Burtt Road, Andover, MA 01810;
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Catherine Srebalus-Barnes
6Pfizer Inc., 275 North Field Drive, Lake Forest, IL 60045;
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Alla Polozova
7Amgen Inc., 360 Binney Street, Cambridge, MA 02142;
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Barbara Rellahan
8Amgen, Inc., 601 13th Street, NW, Suite 1100 North, Washington, DC 20005;
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Daeseok Choi
9CELLTRION Inc., 19, Academy-ro 51, Yeonsu-gu, Incheon 406-840, Republic of Korea;
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Richard Burdick
10Burdick Statistical Consulting, LLC, 7783 Renegade Hill Drive, Colorado Springs, CO 80923;
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Thomas Stangler
11Novartis, Biochemiestraße 10, 6336 Langkampfen, Austria; and
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Emily Shacter
12ThinkFDA, LLC, 710 Erie Ave, Takoma Park, MD 20912
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Abstract

This workshop report summarizes the presentations, the breakout session outcomes, and the speaker panel discussions from the PDA Biosimilars Workshop held September 27–28, 2018, in Washington, DC. This format was deliberately selected for the workshop with the expectation of delivering a post-workshop paper on current best practices and existing challenges for sponsors. The event, co-chaired by Dr. Stephan Krause (AstraZeneca Biologics) and Dr. Emanuela Lacana (CDER/FDA), was attended by 140 agency and industry representatives. The workshop was separated into three major sessions P1: Regulatory Perspective, P2: Challenges in Biosimilar Development, and P3: Demonstrating Analytical Similarity. Each of the three sessions started with agency and industry presentations. Participants then split into two concurrent roundtable discussion groups to hear the answers to questions that had been provided to all participants one week prior to the event. The sessions were recorded. This paper provides consolidated answers to specific case studies for current challenges to sponsors and agencies. In addition, the panel discussion notes following each breakout roundtable session, as well as brief talk summaries of all speakers, are provided. The first session explored the challenges encountered with submission of biosimilar marketing applications from the perspectives of regulatory agencies. Expectations for a successful submission of the chemistry, manufacturing, and controls (CMC) information were described. The second session addressed high-level technical challenges and how to avoid pitfalls frequently encountered during biosimilar candidate development, including data quality expectations, creation of the final control strategy, and strategic choices necessary for candidate selection and development. Both regulatory perspectives and industry experience were shared. The last session explored the use of statistical tools to provide meaningful contributions to the demonstration of analytical similarity. The presentations highlighted common issues and practical challenges that arise during the application of statistical tools.

LAY ABSTRACT: Significant challenges are still-remaining for sponsors and agencies to successfully develop and license Biosimilars. A Biosimilars Workshop was therefore held on 27-28 September 2018 in Washington, DC, to find practical solutions to the remaining challenges. The workshop planning committee with members from industry and agencies prepared specific case studies focused on some of most difficult situations. The workshop was separated into three major sessions (P1 - Regulatory Perspective; P2 - Challenges in Biosimilar Development; P3 - Demonstrating Analytical Similarity) and each session attempted to provide practical solutions to the relevant case studies. This first session explored the challenges encountered with submission of biosimilar marketing applications from the regulatory agencies' perspectives. Expectations for a successful submission of the CMC information were described. The second session addressed high-level technical challenges frequently encountered during biosimilar candidate development, including data quality expectations, the creation of the final control strategy, and strategic choices necessary for candidate selection and development. The last session explored the use of statistical tools to provide meaningful contributions to the demonstration of analytical similarity and practical challenges that arise during the application of statistical tools.

  • Viral clearance
  • Viral safety
  • Viral Clearance Symposium
  • Upstream processing
  • Downstream processing
  • Resin lifetime
  • Facility risk mitigation
  • Submission
  • Strategy
  • Regulatory agencies
  • Health Canada
  • FDA
  • PEI
  • Regulatory perspective
  • Novel format molecules
  • Continuous processing
  • Abbreviations

    AS
    Analytical similarity
    BLA
    Biologics License Application
    BP
    Biosimilar product
    BWP
    Biologics Working Party
    BMWP
    Biosimilar Medicinal Products Working Party
    BSWP
    Biostatistics Working Party
    CDER
    Center for Drug Evaluation and Research
    CEX-HPLC
    Cation-exchange high-performance liquid chromatography
    CI
    Confidence interval
    cIEF
    Capillary isoelectric focusing
    CMC
    Chemistry, manufacturing, and controls
    CMO
    Contract manufacturing organization
    CQAs
    Critical quality attributes
    DS
    Drug substance
    EMA
    European medicines agency
    FDA
    U.S. Food and Drug Administration
    GMP
    Good manufacturing practice
    MoA
    Mode of action
    OCs
    Operating characteristics
    OOS
    Out-of-specification
    PAIs
    Pre-approval inspections
    PK
    Pharmacokinetics
    PPQ
    Process performance qualification
    QTPP
    Quality target product profile
    QWP
    Quality Working Party
    RP
    Reference product
    • © PDA, Inc. 2019
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    PDA Journal of Pharmaceutical Science and Technology: 73 (4)
    PDA Journal of Pharmaceutical Science and Technology
    Vol. 73, Issue 4
    July/August 2019
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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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    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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    • Article
      • Abstract
      • P1: Regulatory Perspective on Biosimilar Marketing Applications
      • Regulatory Perspective on Biosimilar Marketing Applications
      • Evolving EU Views on Analytical Similarity
      • A Reviewer's Perspective of Biosimilar Submissions
      • P1: Summary of Concurrent Breakout Roundtable Discussions
      • P1: Panel Discussion
      • The Trapeze and the Trap Door: Navigating High-Level Technical Challenges in Biosimilar Development
      • Data Quality Considerations for Biosimilar Development
      • Key Lessons Learned from Navigating the Challenges Associated with Biosimilar Product Development
      • A Systematic Approach to Establish a Manufacturing Control Strategy in Biosimilar Development: A Regulatory Perspective
      • P2: Summary of Panel Question and Answer Session
      • P2: Summary of Concurrent Breakout Roundtable Discussions
      • P2: Panel Discussion
      • Moderator: Joel T. Welch, PhD, Review Chief, CDER, FDA
      • P2: Summary of Concurrent Breakout Sessions
      • P3: Demonstrating Analytical Similarity: The Role of Statistical Tools
      • Reflections on Comparability (Similarity) and Methodology
      • Statistical Tools for Demonstrating Analytical Similarity: Range Test, Equivalence Test of Means, and Distribution Comparisons
      • Performance Characteristics of Commonly Used Statistical Approaches in the Evaluation of Analytical Similarity
      • P3: Summary of Panel Question and Answer Session
      • P3: Summary of Concurrent Breakout Roundtable Discussions
      • P3: Panel Discussion
      • Conflict of Interest Declaration
      • Abbreviations
      • References
    • Info & Metrics
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    Keywords

    • Viral clearance
    • Viral safety
    • Viral Clearance Symposium
    • Upstream processing
    • Downstream processing
    • Resin lifetime
    • Facility risk mitigation
    • Submission
    • Strategy
    • Regulatory agencies
    • Health Canada
    • FDA
    • PEI
    • Regulatory perspective
    • Novel format molecules
    • Continuous processing

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