The following table shows the overall process of developing a biosimilar product. Cell Line Preclinical IND Approval Clinical Trials BLA Approval Development & Development Process and Studies Development Determine Design preclinical Apply data on Works to limit Evaluate the structural studies biosimilarity to the number of biosimilar’s equivalence with the FDA’s IND clinical cases safety and reference drug Choose program efficacy appropriate Compare Analyze animal model Design biosimilar with CMP evaluation dispersion of comparative reference drug reference drug Compare clinical studies mechanisms of actions (MoA) 2~5yrs 2~4 yrs 1~1.5 yrs *IND : Investigational New Drug, () *BLA : Biologics License Applications, () *GMP : Good Manufacturing Practice The following table describes each stage of the development process in detail. Stage Notes Task ▹ Cell Line Development The process of developing a stable cell line for biosimilar production. Cell Line ▹ Process Development Development Demonstrate The step of developing a production process based on the newly & equivalent established cell line. Process product quality Characteristically, the production process of biosimilars is similar to that Development of the original product. However, certain improvements in cell culture and other manufacturing stages are applied to achieve competitiveness. The focus of this process is to develop a biosimilar that is qualitatively comparable to the original drug.
The following table shows the overall process of developing a biosimilar product. Cell Line Development & Process Development Preclinical Development and Studies IND Approval Clinical Trials BLA Approval Determine structural equivalence with reference drug Analyze dispersion of reference drug Design preclinical studies Choose appropriate animal model Compare mechanisms of actions (MoA) Apply data on biosimilarity to the FDA’s IND program Design comparative clinical studies Works to limit the number of clinical cases Compare biosimilar with reference drug Evaluate the biosimilar’s safety and efficacy CMP evaluation 2~5yrs 2~4 yrs 1~1.5 yrs *IND : Investigational New Drug, () *BLA : Biologics License Applications, () *GMP : Good Manufacturing Practice The following table describes each stage of the development process in detail. Stage Notes Task Cell Line Development & Process Development ▹ Cell Line Development The process of developing a stable cell line for biosimilar production. ▹ Process Development The step of developing a production process based on the newly established cell line. Characteristically, the production process of biosimilars is similar to that of the original product. However, certain improvements in cell culture and other manufacturing stages are applied to achieve competitiveness. The focus of this process is to develop a biosimilar that is qualitatively comparable to the original drug. Demonstrate equivalent product quality