Usability of NISTmAb reference material for biosimilar analytical development.

Abstract

With the number of approved biosimilars rapidly increasing in the various regulatory jurisdictions, public perception of safety and efficacy of these products have been gradually improving. Establishment of analytical similarity with the innovator product is a key aspect of biosimilar development. It serves as the basis for reduction in the size and/or scope of clinical trials. However, the clinical performance must be consistent with the innovator product. A considerable amount of effort precedes this exercise and requires a suitable reference material to support analytical method development. In view of the high cost as well as limited availability of innovator product in the market, there is a need for suitable reference material which could serve this purpose. The National Institute of Standards and Technology (NIST) have recently created NIST monoclonal antibody (NISTmAb) to support analytical method development and commercialization of monoclonal antibody-based biotherapeutics. In this paper, it is intended to evaluate lifecycle appropriate implementation of NISTmAb, a class-specific reference material in biosimilar analytical development. The results show that NISTmAb can be useful in developing initial platform analytical methods and as an external control for class-specific products. However, as expected, it cannot replace an innovator product or in-house product-specific reference material for analytical similarity assessment. As per regulatory guideline, a product-specific optimization will continue to be a prerequisite for specific analytical properties.