BioCentury
ARTICLE | Politics & Policy

EMA issues biosimilar development guidance

October 30, 2014 2:26 AM UTC

EMA issued final guidance outlining general principles for developing biosimilars in the EU with a handful of changes from draft guidance issued in May 2013 (see BioCentury Extra, May 2, 2013).

The final guidance adds language that reflects EMA's existing practice of allowing extrapolation of evidence of biosimilarity from one indication to others: "If biosimilarity has been demonstrated in one indication, extrapolation to other indications of the reference product could be acceptable with appropriate scientific justification." ...