What is it about?

The paper describes the progress of HX575 from its development through to approval by the EMA in 2007, and summarizes the 10 years of clinical experience since its approval.

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Why is it important?

• 10 years of clinical experience confirms that HX575 provides an effective treatment for CKD-related anemia, with a favorable safety profile. • As of April 2016, HX575 had generated more than 400,000 patient-years of experience worldwide (in CKD and chemotherapy-induced anemia).

Perspectives

The successful approval and clinical use of more than 20 biosimilars over the last decade affirms the integrity of the biosimilar pathway of the EMA.

Andriy Krendyukov

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This page is a summary of: HX575: established biosimilarity in the treatment of renal anemia and 10 years of clinical experience, Drug Design Development and Therapy, December 2017, Dove Medical Press,
DOI: 10.2147/dddt.s146147.
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