FDA – Perguntas & Respostas – Dezembro/2018
Desenvolvimento de produtos biossimilares e biossimilares intercambiáveis.
This guidance document provides answers to common questions from prospective applicants and
other interested parties regarding the Biologics Price Competition and Innovation Act of 2009
(BPCI Act). The question and answer (Q&A) format is intended to inform prospective
applicants and facilitate the development of proposed biosimilars and interchangeable
biosimilars, as well as to describe FDA’s interpretation of certain statutory requirements added
by the BPCI Act.
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