Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2010 Jan;28(1):28-31.
doi: 10.1038/nbt0110-28.

Clinical comparability and European biosimilar regulations

Huub Schellekens  1 , Ellen Moors
Affiliations

Clinical comparability and European biosimilar regulations

Huub Schellekens et al. Nat Biotechnol. 2010 Jan.
No abstract available

PubMed Disclaimer

Comment in

  • In support of the European Union biosimilar framework.
    Schneider CK, Borg JJ, Ehmann F, Ekman N, Heinonen E, Ho K, Hoefnagel MH, van der Plas RM, Ruiz S, van der Stappen AJ, Thorpe R, Tiitso K, Tsiftsoglou AS, Vleminckx C, Waxenecker G, Welin M, Weise M, Trouvin JH; Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP); Biologicals Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP). Schneider CK, et al. Nat Biotechnol. 2012 Aug;30(8):745-8; author reply 748-9. doi: 10.1038/nbt.2322. Nat Biotechnol. 2012. PMID: 22871707 No abstract available.

References

    1. South Med J. 2003 Dec;96(12):1174-86 - PubMed
    1. Nephrol Dial Transplant. 2005 May;20 Suppl 4:iv31-36 - PubMed
    1. Nephrology (Carlton). 2006 Aug;11(4):341-6 - PubMed
    1. J Neurol. 2008 Mar;255 Suppl 1:26-36 - PubMed

LinkOut - more resources