Abstract: The development of biosimilars presents a unique risk profile for biopharmaceutical companies when compared to proprietary biologics development.  This risk profile will be examined and used to explain why biosimilars must be developed and manufactured differently than originator molecules, in order to insure commercial success.   For biosimilars, commercial endpoint oriented process development should start earlier than for originator products.  To buy down risk, “At-Scale” manufacturing may be desirable as early as nonclinical / phase I manufacturing.  Differentiation based on drug product characteristics may be a smart strategy for competing with the originator product and other biosimilars.

1. Due to their unique risk profile, biosimilars need to be developed and manufactured differently than originator molecules.

2. While Critical Quality Attributes must be “biosimilar” to obtain approval, “interchangeability” with the originator may not be readily achievable.

3. Because biosimilars sales will be lucrative, biosimilar markets may be crowded.  One marketing strategy may be to intentionally compete based on differentiated drug product characteristics.