Biosimilars: Harmonizing the Approval Guidelines

Abstract

Biosimilar approval guidelines need rationalization and harmonization to remove the inconsistencies and misconceptions to enable faster, safer, and more cost-effective biosimilars. This paper proposes a platform for a model guideline based on the scientific evaluation of the regulatory filings of the 130+ products approved in the US, UK, and EU and hundreds more in the WHO member countries. Extensive literature survey of clinical data published and reported, including Clinicaltrials.gov, a review of all current guidelines in the US, UK and EU, and WHO, and detailed discussions with the FDA have confirmed that removing the animal and clinical efficacy testing and fixing other minor approaches will enable the creation of a harmonized guideline that will best suit an ICH designation.