Abstract 3414
Background
Patent expirations for biological products have prompted the development of biosimilars, which have comparable quality, safety and efficacy to a licensed biological medicine (the ‘reference’ medicine). HX575 (Binocrit®, epoetin alfa biosimilar) was approved in Europe in 2007 for the treatment of chemotherapy-induced anaemia (CIA).
Methods
The development and approval of HX575 included extensive analytical characterisation and comparison with the reference epoetin alfa, followed by a clinical development programme; this included 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 approval, HX575 has been extensively used in real-world clinical practice.
Results
An array of analytical methods confirmed the similarity of HX575 and the reference epoetin alfa in terms of primary protein structure, higher-order protein structure, isoform pattern, post-translational modifications, receptor binding and biological activity. Phase I studies showed that HX575 and the reference medicine were bioequivalent following intravenous and subcutaneous administration. In a confirmatory phase III study (n = 114), HX575 was effective in treating CIA in cancer patients, and had a safety profile consistent with the therapeutic class and as expected for the therapeutic area. Post-approval data are also available for a range of cancer types; positive results have been reported from a multi-centre retrospective clinical study, single-centre experiences from several countries, and a large-scale prospective observational study. No additional/unexpected safety issues have emerged after 10 years of pharmacovigilance. A pilot study has suggested that HX575 may also be effective for the treatment of anaemia in low-/intermediate-1 risk myelodysplastic syndromes.
Conclusions
As of Feb 2017, HX575 has generated >252,000 patient years’ experience in CIA worldwide. Accumulated data and experience over a decade are reassuring that HX575 is effective and well tolerated for the treatment of CIA in patients with different cancer types.
Clinical trial identification
N/A
Legal entity responsible for the study
N/A
Funding
None
Disclosure
M.S. Aapro: Consulting or Advisory Role: Sandoz Speakers\' Bureau: Sandoz Research funding: Sandoz A. Krendyukov, N. Höbel, A. Seidl: Employee of Hexal AG P. Gascón: Lectureship in Sandoz International GmbH sponsored events