Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar.
Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar. – See more at: http://www.raps.org/Regulatory-Focus/News/2017/01/03/26491/FDA-Finalizes-Guidance-on-Clinical-Pharmacology-Data-to-Support-Biosimilars/#sthash.AlLPUnUu.dpuf