Production and analysis of a biosimilar erythropoietin in Egypt

What is it about?

Although management of chronic diseases has been a major challenge for health care systems in developed and developing countries, biopharmaceuticals have been successful in treating many life-threatening conditions. However, the high cost of these agents restricts their availability to countries where patients and/or health care systems are able to afford them. For this paper, erythropoietin, which has been investigated over a number of years, was chosen as a representative example of SEDICO.

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Why is it important?

Lower cost is the primary reason for prescribing biosimilar products in developing countries. SEDICO supplied EPO with accepted quality and with affordable prices. SEDICO EPO was examined for its quality by analytical methods. The analytical tests to demonstrate comparability and similarity of EPO as a biosimilar product to a reference drug with respect to protein content, activity, physiochemical integrity and stability, as well as immunogenicity are discussed.