Biosimilar safety is important step to be\r\napproval. Biosimilar safety related with the\r\nadverse drug reactions as a result of their\r\npharmacological actions and immunogenicities.\r\nThe purpose of this study is to\r\ndescribing of some consideration about\r\nbiosimilar safety such as Naming\r\n,Immunogenicity,Manufacturing,Pharmacovigilance,\r\nInterchangeability, Labeling,\r\nPreclinical studies, Clinical studies, and\r\nPost-Approval Studies. Naming of\r\nbiosimilar is important step for safety,\r\nImmunogenicity study is important for safety\r\nassessment, Biosimilars, to be approved\r\ninterchangeable, it must meet a higher\r\nstandard ,Preclinical studies, Clinical studies,\r\nPost- Approval Studies , must be achieved.\r\nRecommendations: Reaching to Unified\r\nname, Standard definition for biosimilar and\r\nclose guideline, and demonstrate other\r\naspects about biosmilar safety.
