A New Era in Pharmacotherapy

Jonathan Kay, MD


April 02, 2015

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Hello. I'm Dr Jonathan Kay, professor of medicine at the University of Massachusetts Medical School and director of clinical research in the Division of Rheumatology at the University of Massachusetts Memorial Medical Center, both in Worcester, Massachusetts.

I would like to talk about the recent approval of the first biosimilar agent in the United States. On March 6, 2015, the US Food and Drug Administration (FDA) approved Zarxio™ (filgrastim-sndz),[1] a biosimilar filgrastim, for use in treating neutropenia in a number of situations including for patients receiving chemotherapy; patients having hematologic cell mobilization; and patients with absolute neutropenia. This biosimilar filgrastim is essentially identical in amino acid structure and highly similar in other aspects of its chemical structure to Neupogen® (filgrastim), the agent that has been produced and marketed by Amgen since 1991.[1]

The FDA approved this biosimilar filgrastim on the basis of a totality of evidence including analytical studies that demonstrated identical amino acid sequence to Neupogen; highly similar chemical structures; animal toxicology—which demonstrated highly similar toxicologic profiles; pharmacokinetic and pharmacodynamic studies in humans using an absolute neutrophil count as the pharmacodynamic marker; and a single clinical trial conducted with 218 patients with breast cancer receiving chemotherapy where Zarxio and Neupogen had equivalent number of days with absolute neutropenia and similar safety profiles.[1,2] The approval of this first biosimiliar in the United States is likely to be followed shortly by the approval, or at least the review, of other biosimiliar molecules.[3]

The monoclonal antibody CT-P13, a biosimiliar infliximab, was to have been reviewed by the FDA on March 17, 2015—but this hearing has been postponed with a request for additional data.[4] The biosimiliar infliximab CT-P13 has been approved by the European Medicines Agency[5] for use in the European Union,[6] Japan and Turkey,[7] South Korea,[8] and other countries. It is marketed both as Remsima™ and Inflectra™ and has been available since 2013 in the European Union.[6]

I just returned from a visit to Slovakia, where I spoke with rheumatologists who have been using the biosimiliar monoclonal antibody CT-P13. There it is marketed both as Remsima by Celltrion and Inflectra by Hospira.[9] They said that this monoclonal antibody is effective and has demonstrated no clinically significant difference from Remicade®, the originator biopharmaceutical against which CT-P13 was compared in clinical trials.[5]

This is the beginning of a new era, an exciting time in the United States where biosimilars are here now. I look forward to watching the review and approval of additional biosimilars and look forward to seeing you again on Medscape. Thank you. Please leave your comments below.


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