Development and 10-year history of a biosimilar: the example of Binocrit
| Autor: | Matti Aapro, Andriy Krendyukov, Nadja Höbel, Andreas Seidl, Pere Gascón |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: | |
| Zdroj: | Therapeutic Advances in Medical Oncology, Vol 10 (2018) |
| Druh dokumentu: | article |
| ISSN: | 1758-8359 17588359 |
| DOI: | 10.1177/1758835918768419 |
| Popis: | 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. |
| Databáze: | Directory of Open Access Journals |
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