Data on the stability of biologics and biosimilars are generated during the development of a new product or formulation (see Chapter 3). Stability refers to how long the product remains functionally active and safe, and under what conditions; therefore, it is an important consideration when making formulary and prescribing decisions.
Owing to the relative instability of biologics and biosimilars versus other types of therapeutic molecule, stability is crucial to bear in mind when transporting and preparing the product for use. Data regarding the product’s storage and preparation are generally described in brief in regulatory documentation; however, more comprehensive sources of stability data are available. It is important to be able to interpret data on stability for each individual biologic or biosimilar.
This chapter will evaluate the applicability and quality of stability data, stability information available in different regulatory documentation, and extended stability data and how to access this.