There is a great interest from global companies who are developing biosimilars to pursue interchangeability designation for commercialization of their products in the US. An interchangeability designation will not only allow the substitutability at the pharmacy level without the intervention of a health care provider but the first sponsor who is able to garner interchangeability designation will also receive 12 months of marketing exclusivity. This paper will highlight our current understanding of FDA expectations with regards to demonstrating interchangeability.
US Food and Drug Administration Notice Document. Considerations in demonstrating interchangeability with a reference product; Draft Guidance for Industry; Availability; Extension of Comment Period. https://www.regulations.gov/document?D=FDA-2017-D-0154-0007. Published March 9, 2017. Accessed August 2, 2017.
H. R. 3590-686: Subtitle I—Sense of the Senate Regarding Medical Malpractice. Title VII – Improving Access to Innovative Medical Therapies. Subtitle A—Biologics Price Competition and Innovation. Also known as the “Biologics Price Competition and Innovation Act of 2009.”https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/ucm216146.pdf
RubinsteinE. Letter to the editor: draft FDA Guidance “Considerations in Demonstrating Interchangeability with a Reference Product”: overview and presentation-related concerns. J Manag Care Spec Pharm. 2017; 23:266.
