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Renaissance Washington DC Dupont Circle Hotel

Oct 26, 2016 1:30 PM - Oct 26, 2016 5:00 PM

Formerly Renaissance M Street Hotel, 1143 New Hampshire Avenue, NW, , Washington, DC 20037 , USA

Course: Navigating the Complexities of Biosimilar Clinical Trial Development

Overview

Short Courses are not included in the conference registration and require a separate registration fee.

Short Course Registration: 12:30-5:00PM


In the determination of biosimilarity, clinical data may play a role in assessing the clinical relevance of differences between critical quality attributes of the reference and comparator products. Once the biosimilar developer has answered key questions about why, whether, and how much clinical data should be collected, the work of trial design can begin.

Biosimilar clinical trials differ in significant ways from studies on new biological entities, giving rise to multiple challenges in trial conduct and data generation. Appropriate trial design and anticipation of operational difficulties can help to mitigate these challenges.

This short course will apply learnings from regulatory guidances and from the programs of recently approved biosimilar products to provide insights on optimizing biosimilar clinical trial development, conduct, and data generation. Rather than focusing on any single class of biosimilar, the content will be inclusive of many classes, e.g. growth factors, monoclonal antibodies, fusion proteins.

You will work through the sequential steps of developing a given biosimilar product starting with analytical assessments and proceeding into comparative efficacy trials. Through a broad case study, you will make key decisions as you proceed towards demonstrating a high degree of biosimilarity to the approved reference product. 

Return to DIA Biosimilars 2016

Featured topics

  • Differences between biosimilar clinical trials and studies on new biological entities
  • Challenges in running biosimilar trials (including lack of investigator interest, acquiring the reference product, changes in the reference product, and more)
  • What can go wrong? (PK differences, imbalances in immunogenicity and AEs, non-alignment with references study, and more)
  • Design of biosimilar studies (endpoints, assay sensitivity, equivalence margins, immunogenicity data, safety data)
  • Discussions with regulatory agencies
  • Data to support clinical uptake

Learning objectives

At the conclusion of this short course, participants should be able to:

  • Describe the role of clinical data in demonstrating biosimilarity of a proposed biosimilar product
  • Identify the unique features, challenges, and complexities of biosimilar trials and generating clinical data to address the clinical relevance of differences between reference and comparator products
  • Discuss factors in determining the purposes and amount of clinical data to be collected
  • Describe detailed considerations in designing biosimilar clinical trials to meet regulatory requirements and other study purposes

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