• Distinguishable names will strengthen adverse event tracking and post-marketing surveillance. It is important that adverse events are tracked separately for biologics and biosimilars. The licensed health care practitioner needs to know exactly which product his/her patient is receiving in order to monitor efficacy, adjust dosages and accurately report adverse events if they occur. Long-term, post marketing, registry- based data collection is necessary to monitor for less common—but nonetheless important—adverse events. In the case of an adverse event, the patient needs to be able to communicate to his/her health care provider exactly what is being injected or what was infused. This would be complicated, if not impossible, if the patient or his/her physician is unaware of the specific product the patient received. The complexity of the care of arthritis patients and the complexity of biologic medications make a policy of distinguishable names for biologics and biosimilars critical for maintaining the highest level of patient safety. We believe the FDA shares our commitment to making patient safety a priority and we would welcome an opportunity to continue to dialogue on this topic. Please contact (Name, Title, Organization) at (phone number) or (email address) with questions or for more information. Sincerely, (Name) (Title) (Organization)
Examples have been provided by advocacy and professional societies and have been de-identified. For illustrative purposes only.
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