ACCP Annual Conference 2016


ACCP (American College of Clinical Pharmacology) is a partner organisation of EUFEMED.

 

EUFEMED participated in the ACCP Annual Conference 2016 with Symposium 7:

Establishing Biosimilarity – The European Perception, Experience & Future Trends.

This symposium was initiated by EUFEMED and presented at the 2016 ACCP annual meeting in Bethesda, Maryland.

Goals:

  • To demonstrate the 10-year European experience with biosimilars
  • To assess if European concepts are applicable in the United States.

Objectives:

  • To demonstrate the primary contribution of analytical comparability and its meaning for clinical development
  • To demonstrate the discriminative power of analytics and PK / PD profiles vs. Phase III trials
  • To analyze the European experience with respect to clinical development programs, approval success, post-marketing performance
  • To demonstrate the safety of biologicals vs. biosimilars based on the European experience

 

The symposium attracted numerous scientists for the 4-hour session. The contributions were well recieved and elicited lively discussions. The EUFEMED symposium was a great success.