Industry Trends

The BioPharm Insight 2007 pipeline data summary (see Tables) accentuates a theme that has been repetitively voiced within the research and clinical development community for a number of years:

In October 2007, the US Food and Drug Administration (FDA) launched a program to bolster its generic approval process, which now involves 215 full-time staff members.1 The FDA says it applies as rigorous a process to generics as to brand-name drugs to demonstrate that generics are bioequivalent to their branded counterparts.1 The introduction of new generics to the market offers plans a great opportunity to cut costs and potentially pass the savings to their members.

The total number of generic prescriptions continues to grow at a rapid pace (Table), and the US Food and Drug Administration (FDA) is having difficulties keeping up with the rate of new applications.1 In July 2008, Medco reported a record genericdispensing rate of 63.7%, which reflects a 4.8% increase compared with the second quarter in 2007.2 Keeping with this trend, on July 29, 2008, the FDA approved a generic version of yet another antiepileptic drug (AED)—Depako

Health information technology, and in particular electronic prescribing (e-prescribing), is becoming a major player in any attempt to transform the US healthcare system. A lot of effort is being devoted to e-prescribing today, eliciting greater collaboration among stakeholders and charting new directions in healthcare.

While the market share of small-molecule generics continues to expand—now at 67% of all prescription drugs dispensed in the United States, according to the Generic Pharmaceutical Association (GPhA)1—the issue of biogenerics (or biosimilars, or biologics follow-on) remains unresolved.

Ateam of experts from the Centers for Medicare & Medicaid Services (CMS) released new data in the early days of the new year, detailing the most recent national health spending data for 2007, based on Medicare and Medicaid data, the Census Bureau's data, private health insurance filings with state commissioners, provider surveys, and many other sources.1 These new data from the National Health Expenditure Accounts show that the rate of increase in healthcare spending in the United States grew in 2007 at the lowest rate since 1998.1

The use of generic drugs is one of the key drivers of value in the pharmacy benefit today. Both drug benefit plan sponsors and beneficiaries realize cost-savings by increasing the use of generic drugs when medically appropriate. On average, generic drugs cost 30% to 80% less than their brand-name counterparts.1 It is important for plan sponsors and plan beneficiaries to understand the safety and efficacy of generic drugs, as well as the potential cost-savings.

At the 2008 Annual Policy Conference of the Generic Pharmaceutical Association (GPhA), held in September in Washington, DC, advisors to the presidential candidates Barack Obama and John McCain told GPhA members that both candidates agree on the urgent need to increase access to generic medications—including generic biologics (referred to as biosimilars or follow-on biologics1)—as a way to control the ever-escalating US healthcare costs.

Based on the Forum on Regulation of Follow-On Biologics: Ensuring Quality and Patient Safety that was held at the National Press Club in Washington, DC, in April 2009, to review current issues related to biosimilars legislation. The forum was sponsored by the Jefferson School of Population Health, with a grant support from sanofi-aventis.

The first 100 days of the new administration have produced significant pieces of new legislation that include components of proposed healthcare reform, such as initial funding for comparative effectiveness research (CER). However, many questions remain about the potential scope of healthcare reform and how the new focus on areas such as comparative effectiveness will affect public and private health plans.

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