Biosimilars: Opportunities and Challenges for Nurse Practitioners


      • Overview of the current biosimilar landscape to enable nurse practitioners to appropriately prescribe, educate patients, and prepare their organizations and clinical colleagues for this new product class.
      • Proactive discussion of practical scenarios concerning biosimilars and their substitutability for reference biologics that nurse practitioners will be faced with in the near future.
      • Review of the potential clinical, legal, and operational implications of the differences between generic drugs and interchangeable biosimilars and between interchangeable biosimilars and reference biologics.
      • Strategies for continued education for appropriate and safe use of biosimilars.
      • Understanding of the potential impact on patient access to treatment and cost savings to both patients and health care organizations.


      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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      Martha M. Rumore, PharmD, JD, MS, LLM, FAPhA, is an associate professor at the Touro College of Pharmacy and of Counsel, Sorrell, Lenna & Schmidt, LLP, in New York, NY, and can be reached at [email protected].


      Elizabeth Cobb, PharmD, is an assistant director of Pharmacy at Mount Sinai Beth Israel in New York, NY.


      Maureen Sullivan, PharmD, is an associate professor and chair of the department of pharmacy practice at Touro College of Pharmacy.


      Deborah Wittman, PharmD, BCACP, is an assistant professor at Touro College of Pharmacy and a clinical pharmacist/ambulatory care preceptor at Mt. Sinai St. Luke’s Hospital in New York, NY.