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Biologics, a class of large, complex drugs that are derived from living organisms rather than chemical synthesis,1,2 represent an emerging area of drug therapy. Biologic drugs are important treatment options often used in chronic diseases and cancer. From a health care system perspective, they are a major contributor to rising drug expenditures.3,4 However, as patents for branded products expire, there is an opportunity to develop biosimilar drugs in Canada.1,5 Biosimilars are highly similar versions of biologics already authorized for market,5 which are comparably efficacious and safe, but potentially less expensive.6 As the market for biosimilars grows, their inclusion in hospital formularies can benefit the health care system and improve quality of care by increasing patients’ access to treatment options and reducing expenditures.3 However, biosimilars have classand product-specific characteristics that differ from those of traditional small-molecule drugs,7 and a formulary evaluation to determine efficacy, safety, and cost-effectiveness requires additional considerations. Drugs and therapeutics committees (DTCs) play a critical role in evaluating biosimilars and improving their uptake in acute care. Ultimately, a DTC serves to establish and maintain a formulary that best meets the needs of prescribers, patients, and the health care organization.8 The purpose of this article is to describe one provincial health authority’s practice in adding biosimilars to its acute care formulary. A summary of the available literature on considerations when adding biosimilars to formulary is provided. This information is then applied to the experience of the authors’ health authority, to identify the strengths and challenges of its formulary review and decision process for biosimilar drugs. The article is intended to educate Canadian hospital pharmacists about formulary and practice management tools and principles, as well as educational strategies, to support the safe and effective use of biosimilars. BACKGROUND

Biosimilar Drugs and the Hospital Formulary: A Canadian Experience