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BIO’s Lucky Number 7? Follow-On Biologics Debate Offers Exclusivity Midpoint

Executive Summary

A "split the difference" approach to determining how much exclusivity innovators would receive under a pathway establishing follow-on biologics would give brand products seven years of data exclusivity

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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

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

Biosimilar “Interchangeability” Standard Is Double-Edged Sword For Generics

The interchangeability standard for follow-on biologics set out in Senate legislation creates a relatively smooth pathway for generic firms to seek approval of such products, but could also lead to an extended struggle to win acceptance for such products in the marketplace

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