Biosimilars: Implications for Clinical Practice

Abstract

In 2015, the United States Food and Drug Administration (FDA) approved the first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since that time, the FDA has approved four additional biosimilar tumor necrosis factor α inhibitors, and, in May 2017, the Oncology Drug Advisory Committee voted in favor of approval of an epoetin alfa biosimilar. The patents of several widely used biologic cancer therapies (including trastuzumab, rituximab, bevacizumab, cetuximab, and pegfilgrastim) are recently expired or due to expire in the near future, so the introduction of biosimilars into the oncology treatment armamentarium is imminent. However, their arrival also will introduce challenges, including pharmacy and supply chain management and the need for education of clinicians and patients about the efficacy and safety of these agents. These considerations, along with an overview of biosimilars in the oncology pipeline, will be discussed in this review.

Myelodysplastic syndrome and acute myeloid leukemia after receipt of granulocyte colony‐stimulating factors in older patients with non‐Hodgkin lymphoma

“…However, further studies are warranted given the 2015 FDA approval of a G‐CSF biosimilar, filgrastim‐sndz (Zarxio; Sandoz Inc, Princeton, NJ), and the 2018 FDA approval of pegfilgrastim‐jmdb (Fulphila; Mylan Institutional, LLC, Rockford, IL), which likely will expand the use of this agent. These biosimilars are not approved as interchangeable products; and, unlike small‐molecule generic drugs, the complexity of the protein structures and potential differences in the manufacturing processes also may have implications on safety or outcomes, even for the same biologic medication …”

Safety of Intravitreal Injection of Biosimilar of Aflibercept in Rabbit Eyes

“…Biosimilars are the molecules that should have similar safety, efficacy, pharmacodynamics, and pharmacokinetics, compared to the reference drugs. However, due to different processes of the manufacturing of the biosimilars, they may represent various biological characteristics particularly in terms of stability of the drugs and immunogenicity [ 20 , 21 ].…”

Biosimilars as a Future, Promising Solution for Financial Toxicity: A Review with Emphasis on Bevacizumab

“…Out of the seven biosimilars approved for use in the United States, Zarxiom (filgrastim-sndz), a biosimilar to the granulocyte stimulating factor, filgrastim, was the first biosimilar to be approved in 2015, Please refer to Table 1 [10]. Additionally, pegfilgrastim-jmdb and the pegfilgrastim Lapelga (approved in Canada) are in the process of undergoing the administrative audit process [11][12][13] Biosimilars for a complex biologic monoclonal antibody (mAbs) that are extensively utilized in the management of cancers (like trastuzumab, bevacizumab, rituximab, and cetuximab) are in the late phases of clinical advancement and are demonstrating comparative clinical efficacy to their reference [19][20]. Please refer to Table 2.…”