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Editorial
. 2016 Dec;39(6):188-189.
doi: 10.18773/austprescr.2016.084. Epub 2016 Dec 5.

Safety considerations of biosimilars

Ross McKinnon  1 , Michael Ward  2
Affiliations
Editorial

Safety considerations of biosimilars

Ross McKinnon et al. Aust Prescr. 2016 Dec.
No abstract available

Keywords: bioequivalence; biologic drug; biosimilar drug; generic drug; monoclonal antibody.

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References

    1. McKinnon RA, Lu CY. Biosimilars are not (bio)generics. Aust Prescr 2009;32:146-7. 10.18773/austprescr.2009.072 - DOI
    1. Australian Government Department of Health. Therapeutic Goods Administration. Regulation of biosimilar medicines. Version 2.0, December 2015. www.tga.gov.au/publication/ evaluation-biosimilars [cited 2016 Nov 1]
    1. Kuhlmann M, Marre M. Lessons learned from biosimilar epoetins and insulins. Br J Diabetes Vasc Dis 2010;10:90-7. 10.1177/1474651409355454 - DOI
    1. Praditpornsilpa K, Tiranathanagul K, Kupatawintu P, Jootar S, Intragumtornchai T, Tungsanga K, et al. Biosimilar recombinant human erythropoietin induces the production of neutralizing antibodies. Kidney Int 2011;80:88-92. 10.1038/ki.2011.68 - DOI - PubMed
    1. Emery P, Vencovský J, Sylwestrzak A, Leszczyński P, Porawska W, Baranauskaite A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis 2015;•••:annrheumdis-2015-207588. ; Epub ahead of print.10.1136/annrheumdis-2015-207588 - DOI - PMC - PubMed

FURTHER READING

    1. Council of Australian Therapeutic Advisory Groups. Overseeing biosimilar use: guiding principles for the governance of biological and biosimilar medicines in Australian hospitals. Version 2 – September 2016. Sydney: CATAG; 2016.
    1. McLachlan AJ, Ramzan I, Milne RW. Frequently asked questions about generic medicines. Aust Prescr 2007;30:41-3. 10.18773/austprescr.2007.021 - DOI

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