In March 2010, the US Biologics Price Competition and Innovation Act (BPCIA), or 351(k) pathway, was enacted to allow an abbreviated pathway for the licensure of biosimilar therapeutics. Unlike its predecessor, the Hatch-Waxman Act, the 351(k) biosimilar pathway will unlikely present the observed discounts of chemical generics. Biosimilars are complex in nature and regulatory guidance is more convoluted.

We have characterized the biosimilar environment in the US through a discussion of regulatory pathways and an analysis of US partnerships deals. Supplementing this material is an overview of US approvals, development, reimbursement, and the analytical tools used in characterization of biosimilars.

This report accompanies a published interview with a KOL with an expertise in reimbursement and specialty pharmaceuticals.

For an emerging markets focus, please see the report, "Business of Biosimilars Preview: Outlook for Development of Monoclonal Antibodies in Emerging Markets", published by Citeline in October 2014. For our disclosures, please read the BioMedTracker Research Standards.