Subsequent Entry Biologics Needs Assessment Results 2015

The advent of biologics has improved patient outcomes in terms of patient survival as well as drug delivery. With many of Canada’s top selling biologic molecules facing patent expiration before 2020, a greater number of more affordable subsequent entry biologics (SEBs) will compete with ‘branded’ biologics. SEBs are ‘biologics that are similar to, and enter the market subsequent to, an approved innovator biologic’. These SEBs are of interest, yet present challenges. Certain issues and questions surrounding the differences between SEBs and biologics (eg. cost, manufacturing, approval processes, etc.), need to be considered as more SEBs are developed and become available. This needs assessment focuses on some of these issues.