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Abstract
The science, regulatory, and pharmacovigilance processes for biosimilars are evolving. The Biologics Price Competition and Innovation Act created an abridged approval pathway for biosimilars. The first biosimilar was Food and Drug Administration approved in 2015 with others currently pending approval. As biosimilars become marketed, nurse practitioners will be faced with many challenges, including patient questions regarding them. Nurse practitioners have an important role in the identification of possible safety profile differences between biosimilars and innovator biologicals, especially for immunogenicity. A number of practical considerations need to be addressed including substitutability; off-label prescribing; patient-specific record keeping; and computerized prescriber order entry, education, and reimbursement.
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