Dr. Woodcock Gives Senate FDA Update on Biosimilars Save

Biologics have been a great advance in therapeutics, but at great cost. Although biologics account for less than 1% of all prescriptions in the USA, they account for 28% percent of the cost of prescribed medications.

Healio.com reviewed the September 17th FDA senate hearing (Subcommittee on Primary Health and Retirement Security) wherein Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, provided an FDA update on biosimilar development in the US. Dr. Woodcock answered specific questions about interchangeability and safety, and the lack of final guidance documents on biosimilars. The hearing was moderated by Sen.William Cassidy, MD (R-La.).  An interesting one-hour long video of this hearing can been seen at http://buff.ly/1NUV0Gb.

The guidance documents needed to establish the pathway to biologic development and use. Woodcock responded to several issues.  With regard to guidance on interchangibility she noted the complexity of meeting the statutory definition that would allow for switching from the reference standard to the biosimilar and back again, especially with regard to immunogenicity.  A guidance document on interchangeability is being worked on, she said there are “multiple clearances involved” and cannot be promised by year end.

Sen. Elizabeth Warren(D-Mass.) said eight biologic drugs account for 40% of all Medicare Part B spending, and that biosimilars could save $44 billion over the next 10 years. However, she said the history of generic drugs has shown that savings may not be realized until at least two manufacturers enter the market with the lower priced drug, but only once a known regulatory structure is in place.

Panel members pressed Dr. Woodcock, suggesting the USA was behind other countries.  “The European Medicines Agency adopted a biosimilars pathway in 2003 and approved the first biosimilars in 2006,” Warren said, and added that Health Canada approved its first biosimilars in 2009. “The FDA is building on nearly a decade of experience with the European Union, experience with Canada, and yet 5 years have gone by and we still don’t have any of these guidelines yet, not even in draft form.”

To date, three final guidances have been issued, Woodcock said, including one she called the “foundational guidance” for the development of abiosimilar drug with the framework for manufacturers and developers.