Biosimilars: Clinical Interpretation and Implications for Drug Development

Author:

Mysler Eduardo

Publisher

Springer Science and Business Media LLC

Subject

Rheumatology

Reference25 articles.

1. Pollack A. The New York Times. Published: January 28, 2013. ( http://www.nytimes.com/2013/01/29/business/battle-in-states-on-generic-copies-of-biotech-drugs ).

2. Mysler E, Scheinberg. Biosimilars in rheumatology. A view from Latin America. Clin Rheumatol. 2012;31(9):1279–80.

3. Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, et al. American College of Rheumatology: American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic diseasemodifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008;59:762–84.

4. Schneider CK. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis. 2013;7:315–8.

5. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), et al. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product (draft). 2012. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf (accessed May 2013).

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