Annals

Special Issue: Equivalence of Complex Drug Products: Scientific and Regulatory Challenges (vol 1407)

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Ann NY Acad Sci editorial staff

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Special Issue: Equivalence of Complex Drug Products: Scientific and Regulatory Challenges (vol 1407)

Published: November 2017

Volume 1407

Published since 1824, Annals of the New York Academy of Sciences is the Academy’s premier scientific publication.

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REVIEWS

WHO standards for biotherapeutics, including biosimilars: an example of the evaluation of complex biological products

Ivana Knezevic, Elwyn Griffiths

Complexity of intravenous iron nanoparticle formulations: implications for bioequivalence evaluation

Amy Barton Pai

Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey

Z. Gulsen Oner, Sarah L.J. Michel, James E. Polli

CONCISE ORIGINAL REPORTS

Equivalence of complex drug products: advances in and challenges for current regulatory frameworks

Leonie Hussaarts, Stefan Mühlebach, Vinod P. Shah, Scott McNeil, Gerrit Borchard, Beat Flühmann, Vera Weinstein, Sesha Neervannan, Elwyn Griffiths, Wenlei Jiang, et al.

How to select a nanosimilar

Alain Astier, Amy Barton Pai, Marco Bissig, Daan J.A. Crommelin, Beat Flühmann, Jean‐Daniel Hecq, Josefien Knoeff, Hans‐Peter Lipp, Alberto Morell‐Baladrón, Stefan Mühlebach

ORIGINAL ARTICLES

Iron sucrose: assessing the similarity between the originator drug and its intended copies

Tiziana Di Francesco, Erik Philipp, Gerrit Borchard

Compositional differences between Copaxone and Glatopa are reflected in altered immunomodulation ex vivo in a mouse model

Iris Grossman, Sarah Kolitz, Arthur Komlosh, Benjamin Zeskind, Vera Weinstein, Daphna Laifenfeld, Adrian Gilbert, Oren Bar‐Ilan, Kevin D. Fowler, Tal Hasson, et al.