Commercializing Biosimilar: Challenges, Strategies and Finding Path toSuccess

Abstract

Biosimilars and reference biologics have the same amino acid sequences. Differences in clinically inactive components are generally quite minor. Developments of Bio similar involve a series of complex decision and anyone of which have significant impact on Organization success. Early risk identification allows companies to put preventive measures in place to save development time and maximize return on investment. There are numerous development and regulatory constraints associated with biosimilar development affecting decision of commercialization. It is important to optimize commercialization strategies as regulations are still evolving hence it is vital for the companies to quickly modify biosimilar development strategies matching with the regulatory scenario.