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Biologics, Biosimilars and Biobetters: Strategies for Nonclinical Safety Testing
March 12, 2015 @ 11:00 am - 12:00 pm
Register at the link below to see how new Biologics, Biosimilars, and Biobetters programs using case studies to illustrate strategy choices and the similarities and differences between each program.
New biologics are submitted through an IND process similar to small molecules and require a full battery of safety testing. Biosimilars follow a specific pathway, designed based on an innovator (reference product), and they often have an abbreviated safety testing program.
Our featured speakers will focus on the applicable regulatory guidance that provides a framework for developing a preclinical testing strategy. Biologic programs require careful consideration with respect to species selection, dosing regimens, incorporation of safety pharmacology parameters, pharmacodynamics, bioanalytical/toxicokinetic analysis, and immunogenicity. Biosimilars require particular consideration of the innovator product in order to incorporate design elements from the original preclinical program and to ensure appropriate comparative testing of the biosimilar to the innovator product within the preclinical studies. As the biologic market has grown, the development of Biobetters has been introduced. The intention of producing a Biobetter is to modify an existing Biologic such that there are improvements in efficacy or minimization of toxicity, and a full preclinical safety program is required.