Biosimilar Development Guidelines

Biosimilar development guidelines ensure that new medicines similar to existing biological drugs are safe and effective. Developers must demonstrate that their biosimilar closely matches the original in quality, safety, and effectiveness through rigorous testing and analysis. The process includes detailed comparisons, clinical trials, and quality checks, following strict standards set by regulatory agencies. These guidelines help ensure patients receive reliable, affordable alternatives without compromising health, while maintaining high scientific and safety standards throughout development.