摘要: Biosimilars, also known as follow-on biologics, continue to be an area of great interest in oncology because the potential cost savings and improved access related their use, yet significant confusion remains regarding introduction United States. The regulatory legal hurdles remain poorly defined, companies producing branded products have been battling introduction. European Union provided a pathway for approval 2004, with various agents reaching market since that time. It is important understand nuances discussion experiences clinicians policy makers take active part defining role biosimilars. Several outstanding questions remain, including degree which physiochemical, biologic, quality, clinical end points must demonstrated trials compared use analytic data approval; whether off-label indications should embraced; rules around areas such marketing interchangeability. This article highlights tbo-filgrastim, agent currently marketed biosimilar Europe, its pending US provides insights into these agents.
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