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The biosimilar approval process: how different is it?
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The biosimilar approval process: how different is it?
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References
Sha S, Agarabi C, Brorson K, et al. Trends Biotechnol 2016;34:835–46.
World Health Organization: Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)
Kozlowski S, Woodcock J, Midthun K, et al. New Engl J Med 2011;365;385–8.
FDA: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. Guidance for Industry.
Kay J and Isaacs JD. Ann Rheum Dis 2017;76:4–6.
Schiestl M, Stangler T, Torella C, et al. Nat Biotechnol 2011;29:310–2.
Schneider CK. Ann Rheum Dis 2013;72:315–18.
Scheinberg MA and Kay J. Nat Rev Rheumatol 2012;8:430–6.
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