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

Aapro Matti (1), Krendyukov Andriy (2), Höbel Nadja (3), Seidl Andreas (4), Gascón Pere (5)
(1) Cancer Center, Clinique de Genolier, Genolier, Svájc
(2) Sandoz Biopharmaceuticals, HEXAL AG, Industriestr., Holzkirchen, Németország
(3) Sandoz Biopharmaceuticals, Oberhaching, Németország
(4) Biosimilars, HEXAL AG, Oberhaching, Németország
(5) Department of Hematology-Oncology, Hospital Clínic de Barcelona, University of Barcelona, Barcelona, Spanyolország

Patent expirations for several biological products have prompted the development of alternative versions, termed ‘biosimilars’, which have comparable quality, safety and effi cacy to a licensed biological medicine (also referred to as the ‘reference’ medicine). The fi rst biosimilars developed in oncology were the supportive-care agents fi lgrastim 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 confi rmatory phase III study to confi rm therapeutic effectiveness in CIA. Since its approval, Binocrit® has been extensively used and studied in real-world clinical practice. The accumulated data confi rm that Binocrit® is an effective and well-tolerated option for the treatment of CIA in patients with cancer.

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