Biosimilars: Principles, Regulatory Framework, and Societal Aspects

Author:

Vulto Arnold G.,Barbier Liese

Publisher

Springer International Publishing

Reference65 articles.

1. Autoriteit Consument & Markt (ACM) (2019) Sectoronderzoek TNF-alfaremmers. https://www.acm.nl/sites/default/files/documents/2019-09/sectoronderzoek-tnf-alfaremmers.pdf

2. Barbier L, Simoens S, Soontjens C, Claus B, Vulto AG, Huys I (2021) Off-Patent Biologicals and Biosimilars Tendering in Europe—A Proposal towards More Sustainable Practices. Pharmaceuticals 14: 499

3. Barbier L, Vulto AG (2021) Interchangeability of biosimilars: overcoming the final hurdles. Drugs 81(16):1897–1903. https://doi.org/10.1007/s40265-021-01629-4

4. Barbier L, Declerck P, Simoens S, Neven P, Vulto AG, Huys I (2019) The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars. Br J Cancer 121(3):199–210. https://doi.org/10.1038/s41416-019-0480-z

5. Barbier L, Vandenplas Y, Lacosta TB, Vulto AG (2021) Biosimilar interchangeability: regulatory & practical considerations. Biosimilar development. https://www.biosimilardevelopment.com/doc/biosimilar-interchangeability-regulatory-practical-considerations-0001

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