FDLI issues first e-Advance article on Food and Drug Law Journal

The Food and Drug Law Institute (FDLI) today issued the first e-Advance article to its Food and Drug Law Journal, called "Global Regulatory Standards for the Approval of Biosimilars."

FDLI is a non-profit organization providing a marketplace for discussion of food and drug law issues through conferences, publications and member interaction. For 65 years, its award-winning Food and Drug Law Journal has provided scholarly, analytical articles on all aspects of food and drug law and regulation.  Subscribers to the Food and Drug Law Journal received the e-Advance article ahead of its publication in the Journal later this month.

The Journal article discusses biosimilar standards established in the European Union, Japan, Canada and South Africa and by the World Health Organization. Biosimilars are biologics products that are offered in the marketplace after the innovator's product exclusivity has expired.

The Food and Drug Administration is holding a public workshop November 2-3 on issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act (BPCIA), which was enacted in March 2010.

The BPCIA contains only very general instructions regarding the content of biosimilar application, according to the article. The authors point out that FDA now faces questions similar to those initially faced by the European Union and other countries on how to approve marketing of new biosimilar products.

The authors also highlight several opportunities for FDA leadership on biosimilars.  While the EU, other countries, and the WHO have addressed many critical matters related to biosimilar standards, many continue to struggle with issues related to post-marketing surveillance and interchangeability, the authors state. "FDA is well- positioned to pave the global path forward on these topics," they add.