Posted 19 August 2013
By Raymond A. Huml, MS, DVM, RAC, Kamali Chance, MPH, PhD, RAC, Allen R. Baum, JD, and Eileen Provost
As increasing numbers of highly-successful biologics come off patent, biosimilars are a promising area for investment, offering growth potential that is lacking in many other areas of the biopharma market. This two-part series examines the environment for third-party capital providers, describing key players entering the biosimilars market, ongoing biosimilar trials and the rationale behind partnering. It then examines three hurdles that must be addressed: manufacturing, immunogenicity and data generation (from pharmacokinetic/pharmacodynamic studies and clinical trials).