DNP, Kent State University, 2022, College of Nursing

Biosimilars are pharmaceutical agents approved by the Food and Drug Administration (FDA) as an option to treat multiple medical conditions. In rheumatology, they are used as an option to treat inflammatory diseases such as rheumatoid arthritis (RA) and spondyloarthritis (SpA). The term spondyloarthritis is used to describe a group of disorders, including ankylosing spondylitis (AS), nonradiographic axial spondyloarthritis (nr-axSpA), forms of arthritis associated with psoriasis (PsO), psoriatic arthritis (PsA), and with inflammatory bowel diseases (IBD), among others. The structure and therapeutic effects of biosimilars are similar to previously developed and approved patented biologic pharmaceutical agents. However, they cannot be considered identical, as they are not a product of controlled chemical synthesis but are produced by living cells. The main reason for possible differences is related to patent expiration dates, which typically occur for an active ingredient several years prior to the expiration of patent protection for a manufacturing process. Consequently, competitors may produce the active ingredient, but utilizing a different process, which can often result in variations in impurities and efficacy. With biologic production further complicated by the use of live organisms as production “reactors”, FDA's decision to classify off-patent biologic pharmaceutical agents as “biosimilar” rather than “generic”, as is done for small molecule synthetic pharmaceuticals, underscores the similar rather than identical efficacy of a reference biologic vs. its biosimilar. However, as with small molecule generic pharmaceuticals, biosimilars can be made available at a lower cost making them an economically preferred alternative. Available research data suggests that biosimilars and their reference products have comparable pharmacokinetics, safety, and efficacy. In January of 2019 majority of patients diagnosed with rheumatic diseases managed by the department of rheuma (open full item for complete abstract)

Committee: Lynn Gaddis (Committee Chair); Dana Hensen (Committee Member); Lisa Onesko (Committee Member) Subjects: Nursing