Biosimilars: extrapolation of clinical use to other indications

Abstract

Biosimilars should be approved for all the clinical indications of the reference product based on the totality of the evidence even if there is no clinical safety and efficacy data for each indication. The foundation of biosimilar development is the demonstration that chemical, physical and biological parameters are highly similar to the reference product. Any clinical studies confirm functional sameness rather than establish efficacy and safety de novo since this has already been established with the reference product. However, there is a need to maintain linkage of the biosimilar with the original safety and efficacy data of the reference product in all indications. Reference products are not unchanged throughout the product life cycle due to changes in manufacturing site, scale or process, and new safety and efficacy studies are rarely required. Yet, the reference product retains the same approval in all clinical indications. Most biosimilars will be as close to the reference product as the reference product is to itself after a manufacturing change or even from lot to lot. Thus, analytical and medical sciences justify the approval of biosimilars for all the clinical indications of the reference product.