Clinical case reports raise doubts about the therapeutic equivalence of an iron sucrose similar preparation compared with iron sucrose originator

Abstract

Intravenous iron sucrose has been used to treat iron deficiency and iron deficiency anaemia associated with different chronic diseases for several decades. Despite the complex structure of iron sucrose, copies called iron sucrose similars (ISSs) have been approved according to the generic approach and therefore, therapeutic equivalence is taken for granted. In February 2011, three patients who previously tolerated well the prescribed iron sucrose originator experienced urticaria, oedema and headache within 1 hour after infusion of an ISS that had been substituted for the originator at the pharmacy level. One patient collapsed due to severe hypovolaemic dysregulation and required hospitalisation. Due to emerging evidence that ISSs differ from the iron sucrose originator in safety and efficacy profiles, it seems prudent for physicians as well as patients who require intravenous (i.v.) iron to have available data on therapeutic equivalence of new ISS preparations versus the originator. This may be especially important in patients who are chronically ill and need iron supplementation on a regular, long-term basis.

Keywords::

• Anaemia
• Interchangeability
• Iron deficiency
• Iron sucrose similar
• Non-biological complex drugs
• Substitutability

Transparency

Declaration of funding

The authors did not receive funding for the collection of the data. Medical writing support was funded by Vifor Pharma Ltd, Glattbrugg, Switzerland.

Declaration of financial/other relationships

J.S. has disclosed receipt of consulting fees and membership in advisory committees or review panels of Abbott Laboratories, Falk Pharma, Ferring Pharmaceuticals Inc., Fresenius Kabi Ltd., Immundiagnostik AG, MSD, Nycomed, Shire Pharmaceuticals Inc., and Vifor Pharma Ltd.

A.D. has disclosed receipt of research grants, consulting fees or speaker honoraria from Asahi, Ferring, Falk Foundation, Essex Pharma, MSD, Merckle Recordati, Abbott, Shire, Otsuka, Fresenius, Vifor Pharma Ltd., and Immundiagnostik GmbH.

K.U.C has no conflicting relationships or financial interests.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

Editorial and medical writing support was provided by Alessandra Moglia PharmD, MSc (Vifor Pharma Ltd., Glattbrugg, Switzerland) and Walter Fürst MSc (SFL Regulatory Affairs & Scientific Communication, Basel, Switzerland).

Notes

*Venofer is a registered trade name of Vifor Pharma Ltd., Glattbrugg, Switzerland

^†FerMed is a registered trade name of Medice Arzneimittel Pütter GmbH, Germany