Assessment of structural and functional similarity of biosimilar products: Rituximab as a case study.

ABSTRACT: Biosimilars are products that are similar in terms of quality, safety, and efficacy to an already licensed reference/ innovator product and are expected to offer improved affordability. The most significant source of reduction in the cost of development of a biosimilar is the reduced clinical examination that it is expected to undergo as compared to the innovator product. However, this clinical relief is predicated on the assumption that there is analytical similarity between the biosimilar and the innovator product. As a result, establishing analytical similarity is arguably the most important step towards successful development of a biosimilar. Here, we present results from an analytical similarity exercise that was performed with five biosimilars of rituximab (Ristova®, Roche), a chimer

SUBMITTER: Nupur N 

PROVIDER: S-EPMC5800382 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature