Roche encounters manufacturing issues with epoetin-beta

Biosimilars/News | Posted 27/01/2012 post-comment0 Post your comment

The Spanish regulatory agency has found deviations in the quality of the manufacture of Switzerland-based F. Hoffmann-La Roche’s biological anaemia treatment Mircera (methoxy polyethylene glycol-epoetin beta), a long acting erythropoiesis-stimulating agent; and is recommending patients to change to other epoetins.

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Mircera was approved by EMA in July 2007 and is a long-acting erythropoietin receptor activator indicated for the treatment of patients with anaemia associated with chronic kidney disease.

The problem concerns one of the reagents used in the manufacture of Mircera medicine and the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) announced on 19 January 2012 that it would not release additional lots of this medicine until the detected deviations were solved.

AEMPS has stated that it is reviewing the detected deviations in collaboration with other EU regulatory authorities and EMA. However, in the meantime AEMPS is recommending:

  • not to initiate new treatments with Mircera
  • patients currently being treated with Mircera are switched, under supervision of their doctor, to another erythropoiesis-stimulating agent.

According to the statement from AEMPS, Mircera can be replaced by a short-acting erythropoiesis-stimulating agent in adults with chronic renal insufficiency, without influencing haemoglobin levels.

Mircera sales have been blocked in the US until 2014 due to patent infringement on Amgen’s erythropoietin patents. However, in the rest of the world sales of the medication rose 72% to Swiss Francs 124 million in the first half of 2010.

This highlights the difficulties associated with producing biologicals even for originator companies [1].

If you would like to receive a copy of the above-mentioned AEMPS announcement please send an email to

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1. GaBI Online - Generics and Biosimilars Initiative. Current status of biosimilar development []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jan 27]. Available from:

Source: AEMPS, Roche

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