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      Lesson Learned from Eprex-Associated Pure Red Cell Aplasia

      Kidney and Blood Pressure Research

      S. Karger AG

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          Most cited references 2

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          Bioequivalence and the immunogenicity of biopharmaceuticals.

          The expiry of the first patents for recombinant-DNA-derived biopharmaceuticals will open the possibility of marketing generics, if they can be shown to be essentially similar to the innovator product. However, as shown by the problem of immunogenicity, the properties of biopharmaceuticals are dependent on many factors, including downstream processing and formulation. Products from different sources cannot be assumed to be bioequivalent, even if identical genes are expressed in the same host cells and similar production methods are used. Some of the influencing factors are still unknown, which makes it impossible to completely predict biological behaviour, such as immunogenicity, which can sometimes lead to serious side effects.
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            Eprex-associated pure red cell aplasia and leachates.

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              Author and article information

              Journal
              KBR
              Kidney Blood Press Res
              10.1159/issn.1420-4096
              Kidney and Blood Pressure Research
              S. Karger AG
              978-3-8055-8396-1
              978-3-8055-8397-8
              1420-4096
              1423-0143
              2007
              August 2007
              27 August 2007
              : 30
              : Suppl 1
              : 9-12
              Affiliations
              Departments of Pharmaceutical Sciences and Innovation Studies, Utrecht University, Utrecht, The Netherlands
              Article
              107095 Kidney Blood Press Res 2007;30:9–12
              10.1159/000107095
              17726337
              © 2006 S. Karger AG, Basel

              Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

              Page count
              References: 3, Pages: 4
              Categories
              Paper

              Cardiovascular Medicine, Nephrology

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