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Within 20 days of FDA acceptance of its 351(k) application, the biosimilar applicant shall provide the RPS with a copy of its complete application and detailed manufacturing information including the cell line, expression system, purification process, formulation, and quality control specifications
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Mantsiou C, Karagiannis T, Kakotrichi P, et al
Despite promising preliminary findings, these compounds are generally associated with a poor spatial and temporal control of the treatment as well as poor cancer selectivity, resulting in potential side effects and non-ideal drug doses
