Updated EMA Biosimilar Guidance Seeks Side-by-Side Quality Analysis

Biosimilars’ molecular characteristics should mirror those of the reference biologic as closely as possible, while the performance and consistency of the biosimilars’ manufacturing process should stand on its own, the European Medicines Agency (EMA) says in an updated guideline. Developers should conduct extensive side-by-side analysis of the test and reference products to determine similarities and potential differences, the EMA says. While a biosimilars’ formulation doesn’t need to match the reference biologic, any differences and their potential impact on safety and efficacy should be justified.
International Pharmaceutical Regulatory Monitor