Final Reflection Paper on Extrapolation of Indications in Authorization of Biosimilar Products
06 November 2017
The IPRF Biosimilars Working Group is pleased to announce the publication of a Reflection Paper on Extrapolation of Indications in the Authorization of Biosimilar Products. This Reflection Paper outlines principles for National Regulatory Authorities (NRAs) that participate in the IPRF to consider when evaluating biosimilar products for authorization.
The Reflection Paper compiles common features of various NRA biosimilar guidelines and highlights harmonized scientific considerations on extrapolation for biosimilar products. This final version incorporates feedback received during a consultation held in 2016.Reflection Paper on Extrapolation of Indications in Authorization of Biosimilar Products