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Review
. 2018 Apr 17:10:1758835918768419.
doi: 10.1177/1758835918768419. eCollection 2018.

Development and 10-year history of a biosimilar: the example of Binocrit®

Matti Aapro  1 , Andriy Krendyukov  2 , Nadja Höbel  3 , Andreas Seidl  4 , Pere Gascón  5
Affiliations
Review

Development and 10-year history of a biosimilar: the example of Binocrit®

Matti Aapro et al. Ther Adv Med Oncol. .

Abstract

Patent expirations for several biological products have prompted the development of alternative versions, termed 'biosimilars', which have comparable quality, safety and efficacy to a licensed biological medicine (also referred to as the 'reference' medicine). The first biosimilars developed in oncology were the supportive-care agents filgrastim and epoetin. Binocrit® (HX575) is a biosimilar version of epoetin alfa, indicated in the oncology setting for the treatment of chemotherapy-induced anemia (CIA). The process for development and approval of Binocrit® as a biosimilar included extensive analytical characterization and comparison with the reference epoetin alfa. This was followed by a clinical development program comprising phase I pharmacokinetic/pharmacodynamic studies to show bioequivalence to the reference medicine and a confirmatory phase III study to confirm therapeutic effectiveness in CIA. Since its approval, Binocrit® has been extensively used and studied in real-world clinical practice. The accumulated data confirm that Binocrit® is an effective and well-tolerated option for the treatment of CIA in patients with cancer.

Keywords: Binocrit; HX575; biosimilars; chemotherapy-induced anemia.

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Conflict of interest statement

Conflict of interest statement: MA and PG have acted as advisors to Sandoz. AK, NH and AS are current or previous employees of Sandoz/Hexal AG.

Figures

Figure 1.
Figure 1.
Overview of the biosimilar development process. PD, pharmacodynamics; PK, pharmacokinetics.
Figure 2.
Figure 2.
Comparison of (a) far- and near-UV CD spectra and (b) peptide mapping profiles for Binocrit® and reference epoetin alfa. (Reproduced with permission from European Association of Hospital Pharmacists.) CD, circular dichroism; UV, ultraviolet.
Figure 3.
Figure 3.
Time course of hemoglobin levels. (Reproduced with permission from Karger.)
Figure 4.
Figure 4.
Most frequent cancers included in studies of Binocrit® for the treatment of chemotherapy-induced anemia.
See this image and copyright information in PMC

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