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Biosimilars Introduce New Concerns for Formulary Committees
Due to the unique characteristics of biosimilar drugs compared with small-molecule generic drugs, pharmacy and therapeutics (P&T) committees will need to keep some new considerations in mind when drugs from this class are up for formulary review, according to an article in the October P&T Community.
“Formulary committee best practices for reviewing biosimilars should involve proactively planning and establishing a system to evaluate these products,” the article recommends. “Applying sound principles for formulary management will be critical in the objective and rational evaluation of biosimilar medicines for formulary inclusion.”
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Some of the factors that should be considered include the following:
- Indications for biosimilar medications may not include all indications the branded biologic holds, so committees should not assume a biosimilar can stand in for an originator drug for every on- and off-label use.
- Naming rules have yet to be decided, but if multiple biosimilars produced by different manufacturers end up sharing the same generic name, institutional computer systems that track adverse events may need to be adapted.
- Switching among different versions of biologics and biosimilars could cause immunogenicity reactions in patients. Therefore, when choosing a biosimilar from one of several manufacturers, chose one that has the necessary backup or multisite manufacturing capabilities to provide a reliable and consistent supply of medication.
- When biosimilars hit the market, branded biologics may respond with significant discounts for health systems that continue to use their product. Though it might be enticing, think about how this may affect patients, who may have higher out-of-pocket costs for biologics, and how receiving a biologic while hospitalized and then switching to a biosimilar at the transition of care could impact efficacy and safety.
“P&T committee members will play a leadership role in adopting and using biosimilars appropriately through applying formulary and practice management tools and principles,” the article states. “However, because of the variety and complexity of biosimilars, an especially in-depth analysis will be required when evaluating biosimilars for formulary inclusion.”—Jolynn Tumolo
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