medicines emanate from living organisms and because of that, Biosimilars that are derived from different cell lines and separate manufacturing processes will be slightly different than the innovator products they seek to replicate. This is not a safety issue, as the FDA will deem Biosimilars safe and effective. However, they cannot be an exact copy of an innovator biologic the way generics medicines are to small molecule products. In actuality, there will be three types of biologics in the marketplace: innovator biologics, interchangeable Biosimilars and Biosimilars. All three types of biologics will play a critical role in the delivery of healthcare in the years to come. When crafting the legislation, Congress understood that Biosimilars could not be an exact copy of an innovator biologic; however, they tasked the FDA with the development of a heightened standard called interchangeable Biosimilars that will, with confidence, interact in patients nearly the same way as the innovator product. It is intended that only Biosimilars that meet the heightened standard of interchangeability will be allowed to be substituted at the pharmacy. For instance, in Europe they do not allow product substitution at the pharmacy because they did not develop an interchangeability standard. EU policymakers recognized that Biosimilars could be too different from the innovator product to be freely substituted at the pharmacy. The provision in House Bill (Number) that allows only interchangeable Biosimilars to be substituted at the pharmacy is critical. The transparency measures that are in House Bill (Number) are just as important. As I mentioned biologic medicines are different than small molecule drugs in the way they interact in the body. Because they are derived from cells often found in our own bodies, biologics are generally safe and well received by patients. However, biologics are different than small molecules in that adverse reactions may occur after a patient has been on the product for a long time. Also, it is possible for the body to build up an immune response to the medicines after prolonged use. For this reason, transparency is vital across all three types of biologics. The bottom line is that patients and their physicians should know what products they have received from the pharmacy. Personally, I also want to know what medication is being infused into my son’s body and I want to know that my son’s doctor is aware of any change in medication for him. Legislative efforts in states around the country have had mixed results. I am proud to say that because of your leadership and vision, we can accomplish these goals around transparency through (Section) of the (Name of Legislation), as proposed in House Bill (Number). By utilizing electronic medical records to address the notification and record keeping aspects, we prove once again that (State) is ahead of the curve. We are confident that we will pass groundbreaking legislation on which others states can model their initiatives to pursue both patient access and patient safety.
Examples have been provided by advocacy and professional societies and have been de-identified. For illustrative purposes only.
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