This webinar will review the difference between biologics––any medicinal product manufactured in or extracted from biological sources; and biosimilars–– drugs that are a close, but not identical, copy of an FDA-licensed biologic that are considered “interchangeable”.
The webinar will discuss the role of the Food and Drug Administration (FDA) in approving biosimilars and its policy implications; advantages of using biosimilars; as well as the naming, labeling, interchangeability of biopharmaceuticals; and their substitution. It will also include a question and answer session.
Examples of biopharmaceuticals include vaccines, blood or blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein and living cells.
Presenters: Jerry Clewell––Associate Scientific Director, Biotherapeutics Strategy at AbbVie, Inc.; Emily Alexander–– Director, Regional Lead, U.S. Regulatory Affairs, Biologics Strategic Development at AbbVie, Inc.; Hayden Rhudy–– Director, Therapeutic Area Strategies, Government Affairs at AbbVie, Inc.