With a number of innovator biologicals going off patent, biosimilars present a promising opportunity and a high market potential. However, unlike small molecules, which have known chemical structures, structure activity relationships and well-defined chemical synthesis processes, biosimilars are complex proteins requiring multistep multifaceted manufacturing processes. Hence the development of biosimilars presents unique and complex challenges which need to be strategically planned.

As pharmaceutical business interests spread to Latin America and the Asia Pacific regions, understanding aspects of the regulatory environment in those regions became a critical success factor. This session will provide high-level insight into the regulatory framework for biosimilar product development in key Latin America and Asia Pacific markets. There will be a discussion of a practical case study involving different marketed biosimilar formulations of a known innovator biological product and the practical implications thereof.