Drug Product Considerations for Biosimilars

Abstract

Biosimilars are increasingly important for the expansion of access to life-saving biologics and to reduce the cost of prescription medicine. The design of the drug product for a biosimilar is of utmost importance, as it directly relates to patient efficacy, safety and product quality, even as it defines the similarity of the product to the reference innovator product. There are various components of a drug product: the formulation, the container closure system and/or device, and the drug product manufacturing process that must be considered during any biologic parenteral drug product development. The biosimilar drug product development strategy has to take additional multiple factors into consideration including matching the reference product presentation, intellectual property and the current state of the art in science and technology. This chapter reviews these factors in detail using case-studies from currently approved biosimilars.