Regulatory And Cost Barriers Are Likely To Limit Biosimilar Development And Expected Savings In The Near Future
Open Access
- 1 June 2014
- journal article
- Published by Health Affairs (Project Hope) in Health Affairs
- Vol. 33 (6), 1048-1057
- https://doi.org/10.1377/hlthaff.2013.0862
Abstract
In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars—drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market currently requires large investments of money, fewer biosimilars are expected to enter the biologics market than has been the case with generic drugs entering the small-molecule drug market. Additionally, given the high regulatory hurdles to obtaining interchangeability—which would allow pharmacists to substitute a biosimilar for its reference product, subject to evolving state substitution laws—most biosimilars will likely compete as therapeutic alternatives instead of as therapeutic equivalents. In other words, biosimilars will need to compete with their reference product on the basis of quality; price; and manufacturer’s reputation with physicians, insurers, and patient groups. Biosimilars also will face dynamic competition from new biologics in the same therapeutic class—including “biobetters,” which offer incremental improvements on reference products, such as extended duration of action. The prospects for significant cost savings from the use of biosimilars appear to be limited for the next several years, but their use should increase over time because of both demand- and supply-side factors.Keywords
This publication has 7 references indexed in Scilit:
- Biosimilar competition: lessons from EuropeNature Reviews Drug Discovery, 2014
- BiosimilarsPublished by Elsevier BV ,2014
- Developing the Nation's Biosimilars ProgramThe New England Journal of Medicine, 2011
- Characterizing Markets for Biopharmaceutical Innovations: Do Biologics Differ from Small Molecules?Published by National Bureau of Economic Research ,2010
- Entry and competition in generic biologicsManagerial and Decision Economics, 2007
- The Quantity And Quality Of Worldwide New Drug Introductions, 1982–2003Health Affairs, 2006
- The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringesKidney International, 2005