Biogeneric Exclusivity Debate: At Least 14 Years Or “Hard And Fast” Combo?
Executive Summary
The importance of data exclusivity in ensuring that developers of biologics receive a reasonable return on investment in the face of competition from follow-on products is stressed by the National Venture Capital Association in comments submitted to the House Energy and Commerce Health Subcommittee
You may also be interested in...
Biogenerics Get A Low Score From CBO, But Is BIO Actually The Loser?
The reaction of stakeholders to the Congressional Budget Office's score of potential savings from follow-on biologics illustrates the challenges for the various players as debate on legislation continues
Part D’s Effect On Generic Statins; More ASHE In Brief
Statins are primary Part D generic casualty: The Medicare Part D prescription drug benefit had negligible impact on generic utilization rates, according to a preliminary analysis of Walgreens claim data by James Zhang, Virginia Commonwealth University, and colleagues. In a June 23 presentation at the American Society of Health Economists meeting in Durham, N.C., Zhang reports that the odds ratio of generic utilization for Medicare eligible patients, defined as subjects ages 67-73 in 2006, relative to non-Medicare seniors, subjects ages 61-63, was .98. Authors estimate that potential costs to Medicare due to foregone generic substitutions were $2.1 billion in 2006. Antihyperlipidemics is the only drug class with statistically higher generic utilization for the Medicare-eligible population, the authors report. Merck's blockbuster cholesterol agent Zocor (simvastatin) was a primary focus of insurer generic substitution efforts when the statin lost market exclusivity in June 2006, the first year of the drug benefit (1"The Pink Sheet," July 30, 2007, p. 16). In a separate presentation at ASHE, IMS Health Senior VP-Corporate Strategy Murray Aitken reports that generics account for the same percentage of scripts inside and outside of Part D
Biogenerics Get A Low Score From CBO, But Is BIO Actually The Loser?
The reaction of stakeholders to the Congressional Budget Office's score of potential savings from follow-on biologics illustrates the challenges for the various players as debate on legislation continues