Blog - Shantani

Biosimilar Characterization – Erythropoietin

The demonstration of analytical, pharmacokinetic and therapeutic equivalency of a biosimilar with its reference product is essential for its regulatory approval. In particular, analytical characterization studies demonstrating similarity are crucial part of a marketing authorization application. Though the ‘complete’ characterization is an interminable activity, we as a biopharma solution provider focusses on providing an extensive […]

Biosimilar Characterization – Teriparatide

Regulatory approval of biosimilars depends on the quality and comprehensiveness of the data generated through the comparative analytical, in-vivo and clinical studies. Most crucial factor in establishing the bio-similarity between the biosimilar and the innovator’s product is the detailed analytical structural and functional characterization. Shantani’s aim is to support the regulatory requirements of biopharma developers, by providing […]