Dr. Miletich added, "Minor changes in structure, formulation or impurities can have a significant impact on patients that cannot always be anticipated with analytical studies."
Underscoring the need for clinical trials, Dr. Miletich stated, "In our 30 year history of making biologicals, we have achieved remarkable breakthroughs, developed complex proteins and supplied them to millions of patients in need. However, in the process we have been humbled by unexpected clinical outcomes after analytical and preclinical studies predicted success."
Dr. Miletich also noted that experience with biosimilar applications in Europe demonstrates the need for clinical trials. Approximately half of the biosimilars developed in Europe have had unexpected clinical outcomes at some point in their development. Clinical trials are an essential step in evaluating differences between medicines that analytical and pre-clinical studies indicate are similar. Equally important, we must ensure accountability through accurate tracking and tracing of all biological products.
During his remarks, Dr. Miletich will express the need to continue evaluating products approved as biosimilars after they reach the market to ensure that subtle differences between biologics are well understood. In his testimony, Dr. Miletich indicated that this would be particularly important prior to any biosimilar being approved as interchangeable, since such a determination may result in patients being repeatedly switched between products.
Dr. Miletich went on to say, "An interchangeability determination, if possible, would be very difficult to make and will require significant time and experience. Interchangeability presents both scientific and public health challenges that would need to be addressed before such a determination could be made."
Amgen believes that the agency should ensure that measures are in place to detect and limit th
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