17^th European Biosimilars Congress

Formulation Strategies for Follow-on Biologics

Formulation strategies for follow-on biologics, also known as biosimilars, are essential for ensuring product stability, efficacy, and safety. These strategies focus on developing formulations that maintain the critical quality attributes (CQAs) of the reference biologic while optimizing manufacturing processes and minimizing variability. Formulation considerations include excipient selection, pH adjustment, buffer systems, and stabilization techniques to prevent protein degradation and maintain structural integrity. Additionally, advanced technologies such as protein engineering, controlled release systems, and drug delivery platforms can be employed to enhance the performance and patient experience of biosimilars. Formulation strategies play a crucial role in achieving bioequivalence between biosimilars and their reference products, ensuring consistent therapeutic outcomes and facilitating their successful development and commercialization.