Biosimilars are drugs that match the properties of the original biologic without any meaningful clinical differences. The Biologics Price Competition and Innovation Act of 2009 also categorize some drugs as interchangeable biologics that can be used interchangeably with the reference biological medicine and which can be prescribed by pharmacists without the approval of the prescribing provider, reports Healio Rheumatology.
The quality of a proposed interchangeable biologic—that is to say, the structure, function and even the impurities—are not changed in any manner before the clinical switching study is conducted. In the case of a manufacturer “tweaking” a biosimilar molecule before conducting an interchangeability switching study, it would be viewed as a new biosimilar that would require a completely new and comprehensive data package.
Source: Healio Rheumatology