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Literature DB >> 23222783

Setting the stage for biosimilar monoclonal antibodies.

Christian K Schneider¹, Camille Vleminckx, Iordanis Gravanis, Falk Ehmann, Jean-Hugues Trouvin, Martina Weise, Steffen Thirstrup.

Abstract

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Year: 2012 PMID： 23222783 DOI： 10.1038/nbt.2447

Source DB: PubMed Journal: Nat Biotechnol ISSN： 1087-0156 Impact factor: 54.908

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6 in total

1. Characterizing biological products and assessing comparability following manufacturing changes.

Authors: Arthur J Chirino; Anthony Mire-Sluis
Journal: Nat Biotechnol Date: 2004-11 Impact factor: 54.908

Review 2. Typical pitfalls in applications for marketing authorization of biotechnological products in Europe.

Authors: Christian K Schneider; Gabriele Schäffner-Dallmann
Journal: Nat Rev Drug Discov Date: 2008-11 Impact factor: 84.694

3. Toward biosimilar monoclonal antibodies.

Authors: Christian K Schneider; Ulrich Kalinke
Journal: Nat Biotechnol Date: 2008-09 Impact factor: 54.908

4. Acceptable changes in quality attributes of glycosylated biopharmaceuticals.

Authors: Martin Schiestl; Thomas Stangler; Claudia Torella; Tadej Cepeljnik; Hansjörg Toll; Roger Grau
Journal: Nat Biotechnol Date: 2011-04 Impact factor: 54.908

5. Biosimilars-why terminology matters.

Authors: Martina Weise; Marie-Christine Bielsky; Karen De Smet; Falk Ehmann; Niklas Ekman; Gopalan Narayanan; Hans-Karl Heim; Esa Heinonen; Kowid Ho; Robin Thorpe; Camille Vleminckx; Meenu Wadhwa; Christian K Schneider
Journal: Nat Biotechnol Date: 2011-08-05 Impact factor: 54.908

6. In support of the European Union biosimilar framework.

Authors: Christian K Schneider; John J Borg; Falk Ehmann; Niklas Ekman; Esa Heinonen; Kowid Ho; Marcel H Hoefnagel; Roeland Martijn van der Plas; Sol Ruiz; Antonius J van der Stappen; Robin Thorpe; Klara Tiitso; Asterios S Tsiftsoglou; Camille Vleminckx; Guenter Waxenecker; Mats Welin; Martina Weise; Jean-Hugues Trouvin
Journal: Nat Biotechnol Date: 2012-08 Impact factor: 54.908

6 in total

15 in total

Review 1. Lessons for the clinic from rituximab pharmacokinetics and pharmacodynamics.

Authors: Josée Golay; Gianpietro Semenzato; Alessandro Rambaldi; Robin Foà; Gianluca Gaidano; Enrica Gamba; Fabrizio Pane; Antonello Pinto; Giorgina Specchia; Francesco Zaja; Mario Regazzi
Journal: MAbs Date: 2013-08-08 Impact factor: 5.857

Review 2. Regulatory considerations in oncologic biosimilar drug development.

Authors: Judith C Macdonald; Helen Hartman; Ira A Jacobs
Journal: MAbs Date: 2015 Impact factor: 5.857

Review 3. Expert perspectives on biosimilar monoclonal antibodies in breast cancer.

Authors: J Cortés; G Curigliano; V Diéras
Journal: Breast Cancer Res Treat Date: 2014-02-23 Impact factor: 4.872

4. Rate of primary refractory disease in B and T-cell non-Hodgkin's lymphoma: correlation with long-term survival.

Authors: Corrado Tarella; Angela Gueli; Federica Delaini; Andrea Rossi; Anna Maria Barbui; Giuseppe Gritti; Cristina Boschini; Daniele Caracciolo; Riccardo Bruna; Marco Ruella; Daniela Gottardi; Roberto Passera; Alessandro Rambaldi
Journal: PLoS One Date: 2014-09-25 Impact factor: 3.240

Review 10. Overcoming Barriers to the Market Access of Biosimilars in the European Union: The Case of Biosimilar Monoclonal Antibodies.

Authors: Evelien Moorkens; Clara Jonker-Exler; Isabelle Huys; Paul Declerck; Steven Simoens; Arnold G Vulto
Journal: Front Pharmacol Date: 2016-06-29 Impact factor: 5.810