Last month, the European Medicines Agency (EMA) published its update to its 2006 guidance document for biosimilars: “Guidelines on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues.” The update elaborates on the flexibility that manufacturers have, noting that the impact of a different formulation or container system on safety and efficacy should be justified. This addition aligns the document with the FDA’s guidance on the topic. New to the guidance is the recommended use of critical quality attributes and quality target product profiles (QTPPs) for addressing potential safety issues, including the use of QTPPs early in development. Also new to the update is greater detail on comparability exercises with reference products, including the requirement of “comprehensive side-by-side analyses.”

Source: in-pharmatechnologist.com