Biosimilars

This chapter introduces the concept and definition of biosimilars, discusses the rationale and significance of developing biosimilar drugs, reviews the current landscape of biosimilar regulation and also discusses the future trends and challenges of biosimilar development. It demonstrates the potential impact biosimilars can generate on reducing the cost of biologic drugs. The development of biosimilars provides an opportunity to lower the cost of expensive biologic drugs and increase patients' access to life-saving biologic medicines. As the interest in biosimilars increases, multiple regulatory agencies have established regulatory pathways to regulate biosimilar approval, which is discussed in detail. The European Medicine Agency (EMA) has taken the lead in the regulatory approval framework for biosimilar products, and the US Food and Drug Agency (FDA) was authorized to approve biosimilars by the Biologics Price Competition and Innovation (BPCI) Act passed by the US congress on March 23, 2010.