Biosimilars and Biologics

Biological medicines are far more structurally complex and very sensitive to manufacturing conditions and thus harder to characterize and produce than small molecule drugs. Even minor changes in manufacturing may cause significant variations of the cellular systems used for biological production, also on differences within the structure, stability, or other quality aspects of the top product, all of which have the potential to affect tolerability and/or efficacy and increase the danger of immune responses. Owing to these issues, specific regulatory guidance on biosimilars is continuously evolving, and there's some disagreement on which studies got to be implemented to approve a biosimilars.

• Monoclonal antibody
• Fusion protein
• Biologic drug
• Anti–tumor necrosis factor
• Biotechnologic drug