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PDA J Pharm Sci Technol. 2019 Apr 19. pii: pdajpst.2019.010215. doi: 10.5731/pdajpst.2019.010215. [Epub ahead of print]

PDA Biosimilars Workshop Report (27-28Sep18) - Getting It Right the First Time for Biosimilar Marketing Applications.

Author information

1
AstraZeneca; stephan.krause@astrazeneca.com.
2
CDER/FDA.
3
Medicines Evaluation Board.
4
Health Canada.
5
Pfizer Inc.
6
Amgen Inc.
7
Celltrion Inc.
8
Burdick Statistical Consulting, LLC.
9
Novartis.
10
ThinkFDA, LLC.

Abstract

This workshop report summarizes the presentations, workshop session outcome, and the speaker panel discussions held at the PDA Biosimilars Workshop on 27-28 September 2018 in Washington, DC. This format of this workshop was deliberately selected with an expectation to deliver a post-workshop paper for current best practices and still-existing challenges for sponsors. The event was co-chaired by Dr. Stephan Krause (AstraZeneca Biologics) and Dr. Emanuela Lacana (CDER/FDA) and was attended by 140 agency and industry representatives. The workshop was separated into three major sessions (P1 - Regulatory Perspective; P2 - Challenges in Biosimilar Development; P3 - Demonstrating Analytical Similarity). Each of those three sessions started with agency/industry presentations and then split into a two roundtable discussion groups, instructed to record answers to the same questions which were provided to all participants one week prior to the event. 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. 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 and avoiding pitfalls 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. 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.

KEYWORDS:

Analytical Similarity; Biosimilar Product; Data Quality; Reference Product; Reference Standard; Specifications

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