Biosimilars Resource Center
The editors of JHOP and TOP offer our readers curated content on biosimilar agents.
Biosimilar Utilization Management Within an Employee Health Plan Population
Sara Erickson, PharmD, BCACP; Anna Bartoo, PharmD, BCPS; Amy Wallingford, PharmD; Susan Wescott, MBA, RPh; Chelsee Jensen, PharmD, BCPS, P-RCM, RPh
Biosimilars in Oncology Practice: A Multi-Site Health System Examination of the Use and Perception of Oncology Biosimilars
Ashley Chen, PharmD, BCOP; Taylor Dennison PharmD; Shannon Palmer, PharmD, BCOP; Cameron Czech, PharmD; Erin Mays Eberwein, PharmD, BCOP; Ashley L. Pappas, PharmD, MHA; Mary-Haston Vest, PharmD, MS, BCPS; Walter Russell Laundon, PharmD, MS, BCPS; Maurice Alexander, PharmD, BCOP
Real-World Tolerability and Financial Impact of Biosimilar Bevacizumab-awwb Compared With Bevacizumab in Patients With Cancer
Maher Alhaja, PharmD, BCOP; Candy Tsourounis, PharmD; Hansen Ho, PharmD, BCOP; Richard Fong, PharmD, BCOP
Real-World Uptake and Utilization Patterns of Biosimilars in Clinical Practice
Lee Schwartzberg, MD, FACP; Bhavesh Shah, RPh, BCOP
A Review of Clinical Data Among Biosimilars: Just How Similar Are They?
Dennis Marjoncu, PharmD, BCOP
Assessment and Education of Biosimilars Across an Outpatient Oncology Infusion Network
Presenters: Alexander Quesenberry, PharmD, BCOP, Baptist Cancer Center/Baptist Memorial Health Care Corp; Hannah Alley, PharmD, BCOP, Baptist Cancer Center/Baptist Memorial Health Care Corp, Memphis, TN
Co-Authors: Glenn Roma, PharmD, PhD, BCOP, Baptist Cancer Center/Baptist Memorial Health Care Corp, Memphis, TN; Gregory Sneed, PharmD, BCOP, Sanofi, Cincinnati, OH
Co-Authors: Glenn Roma, PharmD, PhD, BCOP, Baptist Cancer Center/Baptist Memorial Health Care Corp, Memphis, TN; Gregory Sneed, PharmD, BCOP, Sanofi, Cincinnati, OH
Use of Bevacizumab Originator versus Biosimilar Drugs for Oncology Indications in a Real-World Data Sample
Presenters: Bonnie A. Labdi, PharmD, BCOP, The Craneware Group; Rebecca L. Attridge, PharmD, MSc, BCPS, BCCCP, The Craneware Group, Deerfield Beach, FL
Co-Authors: Michelle Winkler, PhD, MPH, The Craneware Group; Alec Gilster, BS, The Craneware Group; Samuel G. Johnson, PharmD, BCPS, FCCP, The Craneware Group, Deerfield Beach, FL
Co-Authors: Michelle Winkler, PhD, MPH, The Craneware Group; Alec Gilster, BS, The Craneware Group; Samuel G. Johnson, PharmD, BCPS, FCCP, The Craneware Group, Deerfield Beach, FL
Biosimilar Uptake and Cost-Savings Analysis Before and After the Implementation of a Pharmacist-Driven Substitution Program Within a National Community Oncology Network
Presenters: Jenny Li, PharmD, BCPS, BCOP, American Oncology Network; Bradley Winegar, PharmD, American Oncology Network, Fort Meyers, FL
Co-Authors: Brooke Peters, PharmD, BCOP; Robert Carr, PharmD, BCPS, BCOP; Camilo Rodriguez, CPhT-Adv, CSPT, PRS; Ashley Kohler-Gerber, CPhT, CSPT; Darell Connor, MHA, FWSPA; Ta’Qyra Freeman, CPhT, CSPT; Kyle Brown; Melody Chang, RPh, MBA, BCOP, American Oncology Network, Fort Meyers, FL
Co-Authors: Brooke Peters, PharmD, BCOP; Robert Carr, PharmD, BCPS, BCOP; Camilo Rodriguez, CPhT-Adv, CSPT, PRS; Ashley Kohler-Gerber, CPhT, CSPT; Darell Connor, MHA, FWSPA; Ta’Qyra Freeman, CPhT, CSPT; Kyle Brown; Melody Chang, RPh, MBA, BCOP, American Oncology Network, Fort Meyers, FL
Comparing the Efficacy and Safety of Reference Drug Filgrastim and Biosimilar Filgrastim-sndz in Pediatric Patients Used for Post–Hematopoietic Stem-Cell Transplant Engraftment or Chemotherapy-Induced Febrile Neutropenia Prophylaxis
Cassandra Rush, PharmD; Ashley Sabus, PharmD, BCOP; Obehi Enabulele, PharmD, MBA, MS; Abby Kim, BA, PharmD, BCOP
Comparing Single-Center Outcomes Between Reference and Biosimilar Granulocyte Colony-Stimulating Factor Drugs Used for Autologous Stem-Cell Mobilization
Trace Bartels, PharmD; Molly Klanderman, PhD, MS; Jaime Rogers, MSN, RN; Kristin Gray, MSN, RN; Heidi Kosiorek, MS; Chris Coughlin, PharmD, BCOP
A Biosimilars Synopsis
Biosimilars are FDA-approved versions of previously approved large-molecule biologic agents (reference drugs) and can offer significant cost-savings.
The abbreviated approval pathway for biosimilar approval was created to help reduce the time and cost of development of biologics without compromising safety and effectiveness; thus, compared with the reference drugs, biosimilars have no clinically meaningful differences in terms of safety, purity, and potency.
Interchangeability
Not all biosimilars have been determined to be interchangeable, but interchangeable biosimilars can be substituted by pharmacists for the reference drug without intervention from the provider who prescribed the reference drug.
Seeking interchangeability is somewhat uncommon, however, because it requires additional costs to conduct clinical studies to demonstrate that no additional risk or reduced drug effectiveness will occur if a patient switches back and forth between a biosimilar and a reference drug. Seeking interchangeable status might also not make sense for the drug manufacturer if the biosimilar agent is typically administered at a hospital or outpatient clinics and not dispensed to the patient by a pharmacy.
Nevertheless, interchangeable and noninterchangeable biosimilar agents are viewed as equally safe and effective, and the FDA is in the process of updating its guidance to the pharmaceutical industry on interchangeable biosimilars, with the goal being fewer tests to demonstrate interchangeability.
Sources
- FDA. 9 things to know about biosimilars and interchangeable biosimilars. June 20, 2024. Accessed November 13, 2024. www.fda.gov/drugs/things-know-about/9-things-know-about-biosimilars-and-interchangeable-biosimilars
- FDA. Biosimilar Regulatory Approval Pathway. Accessed November 13, 2024. www.fda.gov/media/154914/download