Antibody-based pharmaceuticals are emerging as a treatment of many conditions. Biosimilar are biopharmaceutical with similar structure and function to these proteins, often produced and marketed at lower costs. The development of biosimilars is then essential to bring these pharmaceuticals to a larger section of the population.
However, the manufacturing process for biopharmaceutical proteins is a highly complex one, with the functionality of biologics depending on manufacturing conditions, too. Biosimilar development requires a wide range of analytical techniques, in a so-called biosimilar exercise, to assure that the final product is similar to the original molecule from a qualitative, safety, and efficacy point of view. These biosimilar exercises require of course samples of the reference product for comparison.
Since there are differences in the manufacturing conditions between different batches of the same products, the use of samples from a single batch are not sufficient for a biosimilar exercise. For reference, licensing of the etanercept biosimilar SB4 for the European market required the use of 30 batches of the reference biological and 42 analytical methods. Having different production batches as a reference is therefore essential for the development of a biosimilar.