Risk Based Development and Manufacturing of Biosimilars

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.


About Our Speaker:
Neil Schauer is the Principal Consultant at Schauer Biologics Consulting, LLC. where he provides strategic planning and tactical support for process development and manufacturing activities at startup and established biologics companies. At Avaxia Biologics, Dr. Schauer was Senior VP of Technical Operations; where he was responsible for Process Development, Manufacturing, Quality and Program Management. In previous positions (Inspiration Biopharmaceuticals, Hospira, Millipore, Biogen Idec, and Genetics Institute\Wyeth), Dr Schauer held positions of increasing responsibility associated with biologics: technology, manufacturing, process development, and project\program\portfolio management.

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