Table 4.

Educational and Operational Issues Related to Biosimilar Adoption^27,67

Medication Management Process Areas	Key Preparatory Steps for Biosimilars
Formulary analysis	Understand the approval history of the biosimilar, labeled and off-label indications, branded and non-proprietary names, clinical safety and efficacy information, dosage forms, use in special patient populations, and economic aspects. Determine if multiple biologics be on formulary; if multiple products are formulary determine any criteria for use of each product (e.g. indication, patient age, etc). Determine if therapeutic interchange programs will be implemented; if used, obtain P&T approval. Devise a plan for transitions of care, including implications of patient’s insurance coverage.
Order management/Information systems	Differentiate biosimilar and originator product in computerized order entry systems, electronic medication records, medication administration profiles, order sets, and protocols.
Inventory management	Ensure pharmacy buyer has adequate information (e.g. NDC number, wholesaler order number) to purchase biosimilar. If the pharmacy will maintain both biosimilar and originator product, establish par levels for each product.
Financial analysis	Identify the base price, contract price, and reimbursement for biosimilar when compared to originator product Determine financial impact from both health system as well as patient perspective Consider the availability of patient assistance programs.
Education	Provide drug information and other education resources to the pharmacy, physician and nursing audiences for biosimilars Develop appropriate patient educational materials