Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician

Author:

Moots Robert,Azevedo Valderilio,Coindreau Javier L.,Dörner Thomas,Mahgoub Ehab,Mysler Eduardo,Scheinberg Morton,Marshall Lisa

Funder

Pfizer

Publisher

Springer Science and Business Media LLC

Subject

Rheumatology

Reference119 articles.

1. European Medicines Agency. Guideline on similar biological medicinal products. 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf . Accessed 31 Mar 2016.

2. United States Food and Drug Administration. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/UCM291128.pdf . Accessed 31 Mar 2016.

3. World Health Organization. Guidelines on evaluation of similar biotherapeutic products (SBPs). 2010. http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf . Accessed 31 Mar 2016.

4. Scheinberg MA, Kay J. The advent of biosimilar therapies in rheumatology–“O Brave New World”. Nat Rev Rheumatol. 2012;8:430–6.

5. Mysler E, Pineda C, Horiuchi T, Singh E, Mahgoub E, Coindreau J, et al. Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology. Rheumatol Int. 2016;36:613–25. doi: 10.1007/s00296-016-3444-0 .

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