Publications

Biosimilar Therapeutic Monoclonal Antibodies: Gaps in Science Limit Development of an Industry Standard for Their Regulatory Approval, Part 1

Simran J. Kaur, Darryl Sampey, Lester W. Schultheis, Leonard P. Freedman and William E. Bentley.  BioProcess International.  October 2016. Biosimilars are biologically derived pharmaceuticals intended to have clinical similarity to a legally marketed innovator product when that product’s patent or market exclusivity has expired. By contrast with generic small-molecule drugs, clinical performance of a biologic … Continue reading

October 14, 2016 Publications