Biosimilar Products: Understanding FDA Requirements

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Course Description 

This course provides a comprehensive approach to understanding FDA requirements for approval of a Biosimilar Product. Participants receive a foundation of knowledge about the Biosimilar Product approval pathway and the underlying Scientific/Quality/Regulatory principles involved. Guidelines for each aspect of research are provided. The FDA Stepwise Approach to demonstrating Biosimilarity will be discussed. General considerations on animal/clinical/in vitro studies will be reviewed, as well as the FDA’s Totality-of-the-Evidence approach. 

Learning Objectives  

  • Explore the BPCI Act 
  • Describe What a Biosimilar Product is 
  • Describe the Biosimilar Approval Pathway 
  • Review FDA Guidance’s on Biosimilar Products 
  • Explore the “Totality of the Evidence” Approach FDA is Using 
  • Explain the FDA’s Recommended Step-Wise Approach for Biosimilar Products 
  • Navigate Meetings with FDA Relative to Biosimilar Products 
  • Discuss the Quality/Scientific Considerations for Biosimilar Products 

Who Should Attend 

  • Regulatory Affairs Personnel 
  • Research Personnel 
  • Clinical Personnel 
  • Nonclinical Personnel 
  • Manufacturing Personnel 
  • Personnel who require a general understanding of Biosimilar products 


Albert A. Ghignone, M.S., R.A.C. 

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Course Outline 

Day One: 8:30 a.m. – 5:00 p.m.  

  • FDA Law and History 
  • Biologics Price Competition and Innovation Act 
  • Definitions 
  • Regulatory Strategy 
  • FDA Meetings 
  • Biologics Price Competition and Innovation Act; Q&A 

Day Two: 8:30 a.m. – 5:00 p.m. 

  • Biosimilar Product: Scientific Considerations - Biosimilar vs. Interchangeable; Stepwise Approach; Totality-of-the-Evidence; Animal Studies; Clinical Studies; Postmarket Requirements 
  • Biosimilar Product: Quality Considerations - Factors in Assessing Whether Products are Biosimilar; Expression System; Manufacturing Process; Reference Product; Finished Drug Product; Stability  

There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day. 

Interactive Activities
  • Q&A sessions 
  • Disussions sessions 

Registration Fees 

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day. 

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings. 


Click here for our seminar cancellation policy 

Accreditation Information 

ACPE LogoBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-12-055-L01-P. Released 8/12. 

Hold this course at your company! 

For more information, contact Naila Ganatra at (215) 413-2471.