Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session

3414 - Biosimilar epoetin alfa (HX575) for the treatment of chemotherapy-induced anaemia: development, approval and 10 years’ clinical experience

Date

10 Sep 2017

Session

Poster display session

Presenters

Matti Aapro

Citation

Annals of Oncology (2017) 28 (suppl_5): v543-v567. 10.1093/annonc/mdx388

Authors

M.S. Aapro1, A. Krendyukov2, N. Höbel3, A. Seidl4, P. Gascón5

Author affiliations

  • 1 Cancer Center, Clinique de Genolier, 1272 - Genolier/CH
  • 2 Oncology Biosimilars, Hexal AG, Holzkirchen/DE
  • 3 Biostatistics Medical Affairs/late Phase, Hexal AG, Holzkirchen/DE
  • 4 Bioanalytics, Hexal AG, Overhaching/DE
  • 5 Department Of Hematology-oncology, Hospital Clínic de Barcelona, Barcelona/ES
More

Resources

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

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.