Cell line access to revolutionize the biosimilars market.

ABSTRACT: Biologic drugs are notoriously expensive. Biosimilars, though priced lower, are also costly. Analysis of the cost of production of biologics suggests that the cost of manufacture is in many cases less than 10% of the price in high-income countries, and less than a third of the price of biosimilars in India. This in turn implies that the relatively high prices of biosimilars are largely due to the need to undertake laborious reverse-engineering and phase 3 trials to demonstrate clinical similarity. In this article, it is proposed that originators could be required to submit cell line stocks to regulators and disclose details of manufacturing processes. These would be shared with prospective non-originator manufacturers to greatly reduce the investments needed to bring a non-originator biolo

SUBMITTER: Gotham D 

PROVIDER: S-EPMC6051195 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature