Biosimilars: part 1: proposed regulatory criteria for FDA approval

Abstract

Biosimilars, although not identical to their originator product, are expected to become essential in reducing health care costs and improving access to lifesaving drugs. The FDA must find a way to balance rigorous testing to ensure quality, as is done for generic chemical drugs, with providing a cost-efficient way to expedite approvals of these products.

Figure 1)

This illustration depicts the markedly greater structural complexity of the biologic agent erythropoietin, compared with aspirin, a conventional, small-molecule chemical drug.

Figure 2)

Total global sales and period of market exclusivity for top 10-selling biologics in 2011. Bars represent period of market protection from approval date to patent expiration date for each product. The “patent cliff” is highlighted in yellow. Note: Enbrel (etanercept) was granted approval in 2011 for a patent filed in 1995, which can still be challenged by competitors. (From Calo-Fernández B, Martínez-Hurtado J. Pharmaceuticals 2012:5[12];1393–1408. © 2012 by the authors; licensee MDPI, Basel. This open access article is distributed under the terms and conditions of the Creative Commons Attribution license .1)