BioSimilars: Overview for the Home & Specialty Infusion Pharmacy Professional CE# 05-115-20-001-RN
10 Questions
BioSimilars: Overview for the Home & Specialty Infusion Pharmacy Professional CE# 05-115-20-001-RN

Authors: Desiree A. Shouse, PharmD, Darcy Malard Johnson, PharmD, and Logan G. Kostur, PharmD
  1. Differentiate between generic drugs and biolosimilars. 
  2. Describe the FDA approval criteria for biosimilars.
  3. Comprehend the factors driving adoption of biosimilars in the home infusion site of care.
  4. Describe the role of the home infusion pharmacy in facilitating adoption of biosimilars in their patient populations.

The utilization of biologic products has vastly transformed pharmacotherapy options for patients over the last several decades. Patients with complicated diagnoses, most commonly autoimmune and inflammatory diseases and cancer, are now able to achieve resolution of debilitating symptoms and disease remission through the use of monoclonal antibodies, interferons and cytokines, biological response modifiers, and growth factors. With limited side effect profiles and limited interactions with small-molecule drug therapies, biologics have become an important and common treatment option for patients who were unable to obtain successful resolution of symptoms or disease remission with conventional therapies.

Since 2015 when the first biosimilar was approved by the U.S. Food and Drug Administration (FDA), prescribers have seen an increasing number of lower-cost therapeutic alternatives to brand name biologics. Biosimilar products have been predicted save the U.S. health care system between $1.2 and $54 million over the next 10 years. They are also expected to improve clinical outcomes as patients can more easily afford treatment regimens, improving accessibility and adherence rates overall. While the outlook for biosimilars is positive, the very nature of these compounds makes them more complex for health care providers from prescribers to the pharmacists and nurses who oversee their administration.   



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