Events
Duane Morris Partner Frederick Ball to Discuss "Biosimilars: Viewing the New Guidances Through an International Lens"
March 28, 2012 | Webinar
Duane Morris partner Frederick Ball will be part of a panel discussion on the topic of
"Biosimilars: Viewing the New Guidances Through an International Lens" at a Food and Drug Law Institute (FDLI) webinar on Wednesday, March 28, 2012.
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of biosimilar biological products issued by the Food and Drug Administration (FDA) in February and place the draft guidance documents within a global context.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The FDA draft guidance documents represent the FDA's first formal announcements about how it plans to interpret and implement the new biosimilar legislation and touch on wide-ranging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.
To learn more about the webinar, or to register, please visit the FDLI's website.
