Browsing by Author "Long, Genia"

Now showing 1 - 6 of 6

Open Access
Data Exclusivity for Biologics
(Nature Reviews Drug Discovery, 2011-01) Grabowski, Henry; Long, Genia; Mortimer, Richard
Open Access
Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.
(Health Aff (Millwood), 2011-11) Grabowski, Henry G; Kyle, Margaret; Mortimer, Richard; Long, Genia; Kirson, Noam
The evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. Generic drug usage and challenges to brand-name drugs' patents have increased markedly, resulting in greatly increased cost savings but also potentially reduced incentives for innovators. Congress should review whether Hatch-Waxman is achieving its intended purpose of balancing incentives for generics and innovation. It also should consider whether the law should be amended so that some of its provisions are brought more in line with recently enacted legislation governing approval of so-called biosimilars, or the corollary for biologics of generic competition for small-molecule drugs.
Open Access
Implementation of the Biosimilar Pathway: Economic and Policy Issues
(Seton Hall Law Review, 2011) Grabowski, Henry; Long, Genia; Mortimer, Richard
Open Access
The Market for Follow-On Biologics: How Will It Evolve?
(Health Affairs, 2006) Cockburn, Iain; Long, Genia
Open Access
The roles of patents and research and development incentives in biopharmaceutical innovation.
(Health Aff (Millwood), 2015-02) Grabowski, Henry G; DiMasi, Joseph A; Long, Genia
Patents and other forms of intellectual property protection play essential roles in encouraging innovation in biopharmaceuticals. As part of the "21st Century Cures" initiative, Congress is reviewing the policy mechanisms designed to accelerate the discovery, development, and delivery of new treatments. Debate continues about how best to balance patent and intellectual property incentives to encourage innovation, on the one hand, and generic utilization and price competition, on the other hand. We review the current framework for accomplishing these dual objectives and the important role of patents and regulatory exclusivity (together, the patent-based system), given the lengthy, costly, and risky biopharmaceutical research and development process. We summarize existing targeted incentives, such as for orphan drugs and neglected diseases, and we consider the pros and cons of proposed voluntary or mandatory alternatives to the patent-based system, such as prizes and government research and development contracting. We conclude that patents and regulatory exclusivity provisions are likely to remain the core approach to providing incentives for biopharmaceutical research and development. However, prizes and other voluntary supplements could play a useful role in addressing unmet needs and gaps in specific circumstances.
Open Access
Updated trends in US brand-name and generic drug competition
(Journal of Medical Economics, 2016-09) Grabowski, Henry; Long, Genia; Mortimer, Richard; Boyo, Ani