High concentration subcutaneous biological drug products: challenges and advancements

Key Points

• High concentration biological drugs can improve patient compliance and clinical outcomes, but present formulation challenges.
• Studies show that immunogenicity may increase with higher concentrations in subcutaneous delivery, affecting efficacy.
• Observational analysis of existing formulations highlights key challenges in stability and delivery mechanisms for biological drugs.
• Improvements in subcutaneous delivery methods could enhance the pharmacokinetics of biological drugs, indicating robust future potential.