Learning from History: Making Biosimilars a Reality - Genetic ...

FDA desire for specific innovations in biotherapeuticanalysisSteven Kozlowski, M.D.Director, Office of Biotechnology Products2. Three-dimensional StructureAs described previously, proteins must be folded into a three-dimensionalstructure to become functional (sometimes a three-dimensional structure can bemisfolded). The proteins within a biologic will have one major three-dimensionalstructure along with a distribution of other variants differing in three-dimensionalstructure. Our current ability to predict the potency of biologicswould be enhanced if we had improved ability to measure andquantify the correct (major) three-dimensional structure, aberrantthree-dimensional structures (misfolding), and the distribution ofdifferent three-dimensional structures.TESTIMONY BEFORE THESUBCOMMITTEE ON TECHNOLOGY AND INNOVATIONCOMMITTEE ON SCIENCE AND TECHNOLOGYU.S. HOUSE OF REPRESENTATIVESSEPTEMBER 24, 2009