Follow-on protein products: The age of biogenerics?

Abstract

Follow-on protein products (FOPP), also known as follow-on biologics, biogenerics, and biosimilars, are available outside of western markets; however, no FOPP have yet been approved in the US or European pharmaceutical market. This is because of a lack of registration process for the demonstration of pharmaceutical and therapeutic/clinical equivalence. The production of FOPP is a significant opportunity for patients, managed health care providers, and manufacturers with bioprocessing capabilities, assuming the follow-on manufacturer can produce a FOPP at a lower cost without compromising the quality, safety, and efficacy of the product. This may be difficult because there are significant barriers to entry associated with biological production which may result in a smaller price differential between brand and generic products than that seen in regular generics. Presently, there is sparse regulatory guidance from the FDA concerning the development of FOPP, although guidance is expected shortly for well-characterized biologics such as insulin and growth hormone. In addition, legislative changes will be required. Legal issues associated with incorporation of reference label information and therapeutic equivalence designation have to be addressed. A manufacturer needs to demonstrate that the biologic produced is safe and effective as the reference product in the intended patient population. Relevant guidances exist tO'Day from the FDA and EMEA pertaining to production, scaleup, chemistry, manufacturing controls, and comparability of human biological products. FOPP manufacturers must demonstrate the identity, purity, strength, quality, potency, stability, and safety of the biologic. Appropriate testing of the chemical, physical, biological, pharmacokinetic, and immunologie properties of the FOPP and postapproval pharmacovigilance would ensure the therapeutic equivalence and comparability of the follow-on biologic to a reference biologic. © 2008 Humana Press, a part of Springer Sciencc+Business Media, LLC. All rights reserved.