Biosimilars in oncology: from development to clinical practice.
Biologics play an integral role in the treatment of cancer not only for their therapeutic effects and ability to improve outcomes, but also as supportive care agents. Biologics are more complex to manufacture and take longer to bring to market. Because biologics are considerably more costly than small-molecule drugs, their use has placed an increasing economic demand on healthcare systems worldwide. Biosimilars are designed to be highly similar to existing branded biologics, but because biologics cannot be exactly copied, biosimilars should not be referred to as generic, exact versions of the innovator biologic. Biosimilars have the potential to increase access and provide lower cost options for cancer care as patent protection for some of the most widely used biologics begins to expire. Regulatory requirements for biosimilars are evolving, as are global harmonization and/or standardization strategies that can facilitate their robust clinical development. This review highlights critical factors involved with the integration of biosimilars into oncology treatment paradigms and practices. Clinicians will likely seek out practice guidelines and position statements from established scientific societies to help evaluate key information regarding biosimilars, such as efficacy, safety, comparability, and interchangeability with the reference biologic. Automatic substitution, nomenclature, extrapolation of clinical data from one indication to another, as well as parameters for ongoing pharmacovigilance are evolving considerations. Education of physicians and other healthcare providers, payers, and patients about biosimilars may facilitate informed decision making, promote acceptance of biosimilars into clinical practice, increase accessibility, and expedite associated health and economic benefits.
Professor of Medicine and Oncology, University of Maryland Cancer Center, Baltimore, MD. Electronic address: KTKACZUK@umm.edu.
Katherine H
KH
Rak Tkaczuk
Pfizer Emerging Markets/Established Products Medicines Development Group, New York, NY.
Ira Allen
IA
Jacobs
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000592:standards* / Q000627:therapeutic use*; D017277:Drug Approval; D006801:Humans; D007391:International Cooperation; D008495:Medical Oncology / Q000592:standards / Q000639:trends; D009369:Neoplasms / Q000188:drug therapy*; D060735:Pharmacovigilance; D014481:United States; D014486:United States Food and Drug Administration
D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals