In July, the Senate Health, Education, Labor and Pensions HELP Committee gave the thumbs up to the Biologics Price Competition and Innovative Act of 2007 (S. 1695), which lays out a pathway for approving the development of follow-on biologics.
"This Act amends section 351 of the Public Health Service Act to provide for an approval pathway for safe biosimilar and interchangeable biological products (relying in part on the previous approval of a brand product) while preserving the incentives that have fueled the development of these life-saving medicines. "
Draft legislation: Biologics Price Competition and Innovative Act of 2007 (S. 1695)
The New England Journal of Medicine published a good article by Richard Frank, Ph.D., "Regulation of Follow-on Biologics"
DrugResearcher.com ran this piece in July
