Oncology biosimilars : Patient access and administration
This article provides an overview of the pathway of biosimilars , from manufacturer to patient access and administration
Welly Mente PharmD Ashim Malhotra PhD California Northstate University College of Pharmacy
Erika Young PharmD Candidate Northeastern University , College of Pharmacy
Nivaz Brar MD Stanford University College of Medicine
Bin Guan MSN University of California at Davis Medical Center
Xiaodong Feng PhD PharmD California Northstate University College of Pharmacy , CA , USA
By definition , a biosimilar is designed to offer comparable clinical efficacy , safety , and lower cost with a shorter and cost-effective approval pathway , to the original biologic to promote an affordable and accessible therapy for patients . It has been projected that the use of biosimilars will reduce the direct cost on biologics by billions of dollars . 1 However , despite this obvious financial advantage , patients would appear to be ill-informed about biosimilars . 2 Patient anxieties over biosimilars were highlighted in a national survey of 629 French rheumatology patients , which found that their greatest concerns focused on the molecular nonsimilarity of biosimilars ( 46 %), efficacy ( 60 %) and safety ( 57 %) in comparison to the reference product . 3 Furthermore , given that the Food and Drug Administration ( FDA ) uses an abridged licensure pathway to approve biosimilars , it may lead some patients to erroneously believe that biosimilars are in some way inferior to the reference product . The reduced cost of biosimilars enables healthcare providers to treat a larger number of patients for a given budget and thus offer affordable and highquality care . In recent years , attention among biosimilar manufacturers has increasingly focused on the ‘ end-to-end ’ manufacturing process and the
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