Considerations for a Successful Biosimilars Program

Duration: 60 Minutes
By 2020, the global biosimilars market is expected to surpass $6 Billion. From 2015 through 2020, 39 biologic drugs with combined U.S. sales of $41 B, roughly 30% of the market, will lose their marketing exclusivity. The result is increased interest in the biotech industry to gain entry into this potentially lucrative market. However, the combination of rigorous regulatory requirements, the potential for high manufacturing complexities, and innovative strategies by drug manufacturers to restrict entry of new players is restraining growth in this market. In this webinar, we will explore the challenges encountered by the industry in the development of a successful biosimilars program.
Biosimilars Program
Instructor: Paul W. Price
Product ID: 501570
Objectives of the Presentation
  • Current regulatory guidelines and considerations for bringing biosimilars to market
  • Strategies for developing and manufacturing biosimilars
  • Integration of biosimilarity and comparability into developing biosimilars
  • Identifying challenges encountered with extrapolations and Interchangeability
  • CMC regulatory challenges and considerations
  • Nonclinical and clinical challenges
Why Should you Attend
A full blown biosimilars market offers huge potential in bettering patient outcomes and reducing treatment costs, as well as opening the doors to a multi-billion dollar market. This training will be helpful for those looking for a better understanding of the challenges faced by biosimilars developers as well as those who seek to implement a biosimilars program or to further develop an existing biosimilars strategy.

Areas Covered
  • BPCI Act of 2009
  • Current regulatory guidelines and considerations for bringing biosimilars to market
  • Strategies for developing and manufacturing biosimilars
  • Integration of biosimilarity and comparability into developing biosimilars
  • Identifying challenges encountered with extrapolations and Interchangeability
  • CMC regulatory challenges and considerations
  • Nonclinical and clinical challenges
Who can Benefit
  • Senior Scientists and above
  • Functional Area Managers
  • Vice Presidents
  • Directors
  • Project Managers
  • Quality/Regulatory Managers
  • Principle Investigators
  • Investors
Topic Background
Biosimilars can be likened to originator biologics the way generics are to small molecule drugs. By 2020, the global biosimilars market is expected to surpass $6 Billion. The increasing pressure to decrease healthcare costs, growing demand, positive outcomes of ongoing clinical trials, and increasing numbers of biologic drugs losing exclusivity are contributing to the growth projections. Indeed, from 2015 through 2020, 39 biologic drugs with combined U.S. sales of $41 B, roughly 30% of the market, will lose their marketing exclusivity.

The U.S. market was opened up when the FDA approved the first biosimilar product, Xarxio, in March 2015. However, circumstances such as manufacturing costs, rigorous regulatory requirements, and innovative strategies by drug manufacturers to restrict entry of new players are restraining growth in this market.

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Instructor Profile:
Paul W. Price, Ph.D. is a Senior Consultant at Biologics Consulting with over 25 years' experience in the Biotechnology Industry. Paul is part of the CMC-Analytics and Formulations Team, and also serves with the Early Development and Biosimilars Task Forces. He assists clients with design and implementation of biologics development and manufacturing projects; design, development, qualification and validation of process and release analytics; developing Project Management strategies for product development including Risk Management, Quality Oversight, and Technology Transfer; and Identification, management, preparation, and submission of Government Contract and Grant Proposals.

Paul's career has included work at Biocraft Laboratories and Barr Laboratories, Beckman Coulter, Inc., Abeome Corp., and Paragon Bioservices, as well as working as an independent consultant. As Principle Scientist at Paragon, he lead the planning and implementation of biologics development projects, including vaccines, viral-vectored products, monoclonal antibodies, protein therapeutics, and diagnostics. In addition, Paul held the position of Director of Government Grants and Contracts, where he oversaw the development, management, and submission of Government contract proposals and Grant applications. He is a SME in immunology, infectious diseases, microbiology, virology, and cancer, as well as biological assay development, Risk Management, and Quality oversight.

Dr. Price holds a B.S. in Marine Biology and a M.S. In Microbiology from Fairleigh Dickinson University, he earned his Ph.D. in Biology (Immunology) from Georgetown University, and completed post-doctoral studies at the University of Maryland, School of Medicine.
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