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Achieving interchangeability requires demonstrating, through switching studies, that alternating between the reference product and biosimilar does not produce greater safety or efficacy differences than using the reference product alone

- Not FDA-approved yet commonly available through research and compounding pharmacies

J.LeeJ.KimY.YoonJ.ParkK.et al (2010)

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If the biological stability is affected, its biological activity may decrease or be lost, thus failing to achieve the expected therapeutic or research effect

ShimizuKAsakawaTHaradaNFukumotoDTsukadaHAsaiTet al