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Program Description

Speakers in this webinar will discuss the three draft guidances on development of biosimilar biological products issued by the Food and Drug Administration (FDA) in February and place the draft guidance documents within a global context. They will examine the approach taken by FDA and how it compares and contrasts with the approach recommended by the World Health Organization in its recent guidance, as well as the approach taken by regulators in Europe, Japan, China, Brazil, Canada, and other countries.


The FDA draft guidance documents represent FDA's first formal announcements about how it plans to interpret and implement the new biosimilar legislation and touch on wide-ranging issues like the scope of the structural comparisons needed, the preclinical and clinical data needed, extrapolation of indications, the use of foreign comparator products in addition to FDA-approved reference products, immunogenicity testing, and pharmacovigilance. During the webinar, special attention will be paid to the ongoing European efforts to revise and update their overarching biosimilar guidelines, now a half dozen years old, and to synergies between the two regulatory systems and cooperation between the two regulators (FDA and EMA). Recent developments in Latin America and Asia will also be noted. Implications for global innovative development programs and global biosimilar development programs — and for the private bar and industry — will be explored.


Accessing the Draft Guidances:

  1. "Scientific Considerations In Demonstrating Biosimilarity to a Reference Product" 

  2. "Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product" 

  3. "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009"


Who Attended


  • In-house counsel (regulatory, intellectual property, and business strategy) and in-house regulatory policy and global government affairs personnel; and regulatory affairs professionals and regulatory or public policy consultants focusing on biologics and biosimilars. 
  • Lawyers in private practice who provide advice to global biologic, biopharmaceutical and/or biosimilar companies. 
  • Anyone seeking information on the Draft Biosimilar Guidances issued by FDA on February 9, 2012, and how it affects the international business landscape for the biopharmaceutical industry.