EMA Opens Biosimilars Guidelines for Comments

On May 31, 2012, EMA released a revised guideline to help the industry better address quality control of biosimilar drugs. The revision document, Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (Rev. 1), serves as an update to the association’s 2006 biosimilars guideline of the same name, which covered the molecular characteristics and quality assurance of a biosimilars compound. The 2006 document also addressed the performance and consistency of the manufacturing process of the biosimilar on its own.

The revised guideline provides more detail on how biosimilars manufacturers should compare their proposed compounds to those drugs already on the market. The guideline states that the purity and impurity profiles of drugs and APIs should be compared both qualitatively and quantitatively using state-of-the-art and orthogonal methods.

The EMA revision goes a bit further than the 2006 guideline to provide industry with more detail on comparability exercises for quality, considerations for reference drug products, analytical methods, physicochemical characterization, biological activity, and purity and quality attributes for relevant specifications of the biosimilar.