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New actions advancing FDA’s biosimilars policy framework include a Q&A and a draft Q&A on scientific and regulatory considerations for the development of biosimilar and interchangeable products. Also issued were a draft Q&A and final guidance on how the FDA intends to transition a small subset of biological products, such as insulin and human growth hormone, which are currently regulated as drugs, to a license status under the “Deemed to be a License” provision of the Biologics Price Competition and Innovation Act [BPCI]. FDA Commissioner Gottlieb issued a statement describing the guidances. A proposed rule was also released that: ● amends the definition of a “biological product” ● provides interpretation of the statutory terms “protein” and “chemically synthesized polypeptide,” and ● incorporates changes made by BPCI. Electronic comments on the propose rule must be submitted on or before February 25, 2019.
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