Table 3. Considerations for pharmacists evaluating biosimilars for formulary inclusion.

Safety and efficacy
Product characteristics11	Are there any differences in formulation or excipients of the biosimilar under consideration versus the reference product? Are there any differences in compatibility (eg, injection pain, interference with laboratory assays) between the biosimilar under consideration and the reference product?
Clinical data10	Is the amount of available clinical data sufficient for the indications being considered for formulary inclusion? Have postapproval studies been evaluated? Are relevant clinical data from international studies available for review?
Immunogenicity10	Are there any differences in the immunogenic profiles between the biosimilar under consideration and the reference product with respect to the incidence of – Infusion reactions? – Neutralizing antibodies?
Manufacturer considerations
Medication availability31	Are there any differences in clinic administration and/or retail availability between the biosimilar under consideration and reference product that may affect the overall availability of the products? Does the manufacturer have a process to ensure a reliable and uninterrupted supply of the product? – Does the manufacturer maintain adequate levels of reserve product in stock? Does the manufacturer have the ability to increase production at another location, if necessary, to meet demand?
History of shortages and recalls31	Has the manufacturer experienced shortages of this product or other products? – If so, what was the cause and how often have shortages occurred? Has the product ever been recalled because of quality concerns? Has the manufacturer had other products recalled as a result of quality concerns?
Handling practices31	Does the manufacturer adequately document and maintain controlled temperature during distribution of the product? Does the manufacturer take the necessary steps to prevent exterior contamination of vials?
Supply chain security	Does the manufacturer apply and document adequate security technologies for product authentication, warehouse/cargo security, and market surveillance to detect potential product diversion or counterfeits? – Are there any differences between the biosimilar under consideration and reference product with respect to security systems and procedures at the warehouse, pallet, truck, and carrier level?
Anticounterfeit protection	Does the manufacturer have a program in place to guard against counterfeiting?
Hospital and patient considerations
Packaging and labeling	Are the containers, packaging, and labeling well-designed and easy to read? Are there any differences in packaging between the biosimilar under consideration and reference product? Are there any differences in warnings on the label regarding handling between the biosimilar under consideration and reference product?
Product storage	Are there differences in shelf life or storage requirements between the biosimilar under consideration and reference product? Are there any differences in light sensitivity between the biosimilar under consideration and reference product? Do any differences in storage conditions offer an advantage or disadvantage in terms of patient care? Will both the biosimilar under consideration and reference product be stocked based on differing indications between the products or for patients admitted on the reference product? – If so, how will the biosimilar under consideration and reference product be stored to eliminate the potential for a dispensing error? Are there any differences in product configuration (eg, size or shape) between the biosimilar under consideration and reference product that could impact compatibility with a robotic compounder?
Product administration	Are there any differences in the delivery system or device between the biosimilar under consideration and reference product (eg, autoinjector)? – Does the labeling for the biosimilar under consideration include information on delivery? – What is the plan for educating patients receiving a biosimilar with a different delivery system/device from the reference product? Does the biosimilar under consideration have fewer approved routes of administration than the reference product? If provided in vials, are there any differences in the amount of excess product between the biosimilar under consideration and reference product? Are there any differences in pharmacy technician time and techniques for compounding between the biosimilar under consideration and reference product? Are there any differences in timing of administration or patient experience that may affect patient and nurse preference between the biosimilar under consideration and reference product?
Interchangeability4,5,14,31	Does the biosimilar under consideration meet clinical and regulatory criteria to be freely substituted for the reference product (and vice versa)? Should a therapeutic equivalence program be established for use within the hospital or health system and be approved by the P&T Committee and medical staff? Will patients who are taking the reference product at home be required to convert to the biosimilar under consideration? – If yes, how will care transitions be managed? – Will policies be developed to specifically manage care transitions?
Variety of indications5	Is the reference product currently being used for multiple indications? – If so, is the biosimilar under consideration being evaluated for all those same indications, including FDA-approved indications and those considered standard of care?
Product naming5	How is the specific product recorded in the medication dispensing documents? Will the selected name ensure traceability of adverse events to the specific product? Are any special procedures required to ensure traceability of the biosimilar under consideration?
Information technology support	Does the hospital have a robust information technology infrastructure to support – Distinguishing the biosimilar under consideration from the reference product during order entry? – Tracking which product was administered (biosimilar under consideration versus the reference product)? Is the labeling of the biosimilar under consideration compatible with the facility’s current technology (eg, bedside barcode scanning)?43
Economic considerations 4,5	Are reimbursement support and other programs (eg, product replacement, copay assistance, and insurance denial support) available for uninsured/underinsured patients receiving the biosimilar under consideration? – If not, how will this affect the overall cost of adding the biosimilar under consideration to formulary? Will all government and commercial payer policies apply equally to both the reference product and the biosimilar under consideration? Are there any differences between the biosimilar under consideration and reference product with respect to the 340B Drug Pricing Program? Are there any differences between the biosimilar under consideration and reference product with respect to ease of access to the product (eg, based on payer requirements for preauthorization)? Are there financial and/or legal risks of using the biosimilar under consideration for an unapproved indication for which the reference product has approval? Does the difference in cost for the biosimilar under consideration versus the reference product support a full formulary conversion?
Patient education5	Does the manufacturer provide patient education materials at a 6th grade reading level? – Do materials appropriately distinguish biosimilars and generics? Is it necessary to develop materials for educating patients on the interchangeability of biosimilars?