FDA Releases Final Biosimilar Guidance

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-05-06-2015, Volume 11, Issue 5

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

The documents address comments from various industry perspectives and, according to FDA, “are intended to provide predictability and to make clear the scientific and regulatory considerations for sponsors initiating biosimilar development programs.”

Source: FDA