Thursday, September 17th, we attended the UNITED STATES SENATE Health, Education, Labor, and Pensions Subcommittee. Dr. Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA), gave testimony to the UNITED STATES SENATE Health, Education, Labor, and Pensions (HELP) Subcommittee on the FDA’s progress report on biosimilar implementation in the United States. She addressed important issues such as the implementation of “successful [biosimilar] naming system”, the potential of a patient’s autoimmune response system being at risk due to “the degree of variability in the [switching between biologic and biosimilar] drugs that can lead to a stimulated immune response”, as well as stating how it is the FDA’s goal to “gain and maintain” trust from the healthcare and patient communities in how biosimilars are safely and effectively dispensed. As Dr. Woodcock stated, “We [the FDA] have to get the science right.”
Content on HealthUnlocked does not replace the relationship between you and doctors or other healthcare professionals nor the advice you receive from them.