- Browse by Subject
Browsing by Subject "Drug Approval"
Now showing 1 - 2 of 2
Results Per Page
Sort Options
Item The approval process for biosimilar erythropoiesis-stimulating agents(American Society of Nephrology, 2014-09-05) Wish, Jay B.; Department of Medicine, IU School of MedicineA biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage of biosimilar drugs is that they are significantly less expensive than the reference products, allowing for increased accessibility and cost savings. Recognizing these advantages, the US Congress passed the Biologics Price Competition and Innovation Act in 2009 as part of health care reform. The Biologics Price Competition and Innovation Act allows sponsors of biosimilar agents to seek approval by showing structural and functional similarity to the reference agent, with the extent of required clinical studies to be determined on the basis of the degree of biosimilarity with the reference product. The goal is to bring biosimilar agents to the market more efficiently while still protecting the safety of the public. The European Union has had such a process in place for a number of years. Two biosimilar epoetin agents have been approved in the European Union since 2007, and their companies are conducting trials to seek approval in the United States, because Amgen's patent protection for epoetin alfa expires in 2014. Trials completed for European Union approval of both agents showed similar efficacy and safety to the reference epoetin alfa. As with all biologics, immunogenicity concerns may persist because of the fragility of the manufacturing process and the worldwide experience with pure red cell aplasia as a result of epoetin therapy. The uptake of biosimilar epoetins after approval in the United States will depend on the balance of cost advantage against safety concerns. Competition in the marketplace will likely decrease the cost of the reference agent as well.Item What Will It Take to Reap the Clinical Benefits of Pharmacogenomics?(Food & Drug Law Journal, 2006) Evans, Barbara J.Genetically targeted drug and biologic therapies promise a new era of personalized medicine, but there has been frustration with how slowly these therapies are moving from concept to actual clinical application. Various legal and regulatory barriers threaten to delay translation of basic discoveries into approved products and to slow the clinical uptake of new therapeutic products as they become available. There is a pressing need to reach consensus on what these barriers are, so that they can be addressed in a timely and effective manner. This paper explores what some of the key barriers may be. It examines: (1) legal, regulatory, and commercial barriers to “successive improvement” of existing drugs through improved targeting strategies; (2) barriers to cooperative, multi-party development of targeted therapies; (3) methodological problems in assessing the incremental health and economic benefits of an improved targeting strategy; (4) limitations of traditional product labeling as a medium for communicating timely, clear information about drug targeting to clinicians and the need to create new mechanisms within the medical profession to manage and communicate this information; and (5) difficulty defining the appropriate line between regulation of medical products and regulation of medical practice, in the case of targeted therapies.