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Regulatory Focus™ > News Articles > CMC, Preclinical and Clinical Considerations for Biosimilars and Follow-on Biologics

CMC, Preclinical and Clinical Considerations for Biosimilars and Follow-on Biologics

Posted 01 January 2008 | By

As noted in the article "Follow-on Biologics in the EU and US," on page 8 of this issue, biologics are created from living organisms, either naturally or via genetic manipulation (e.g., monoclonal antibodies), or are manufactured from complex building blocks of living organisms (e.g., siRNA, aptamers, etc.). In either case, they demonstrate considerable molecular complexity and heterogeneity, and are more difficult to characterize physicochemically than synthetic chemical entities. These differences are reflected in the regulatory agencies' refusal to adopt the same paradigm for generic biologic drugs as for traditional small molecule products.

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