Generic News Capsules

MARCH 01, 2009

Generic Heart Meds Equally Good, Study Finds

A recently released analysis of 9 subclasses of cardiovascular medications has found no evidence to support the notion that brand name drugs used in cardiovascular disease are superior to generics. The analysts came to this conclusion after examining 47 articles reporting peerreviewed research on these medications.

?This scientific review is the latest in a growing number of authoritative statements from the FDA and others proving that it is safe to substitute an FDAapproved generic medicine for a brand name product,? said Kathleen Jaeger, president of the Generic Pharmaceutical Association.

The meta-analysis, reported in the December 3, 2008, issue of the Journal of the American Medical Association (JAMA), also revealed that a substantial number of editorials counsel against the interchangeability of generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution.

Jaeger added that, ?it is noteworthy that the JAMA article states, ?popular media and scientific journals could choose to be more selective about publishing perspective pieces based on anecdotal evidence of diminished clinical efficacy or greater risk of adverse effects with generic medications. Such publications may enhance barriers to appropriate generic drug use that increase unnecessary spending without improving clinical outcomes.??

Canada Sees Big Savings with Generics . . .

A new report from the Canadian Competition Bureau estimates that up to $800 million a year would be saved if generic drugs were sold in a more competitive market.

The study, ?Benefiting from Generic Drug Competition in Canada: The Way Forward,? states that the savings will only grow as several blockbuster brand name drugs come off patent in the next 3 years and become available in generic versions. ?Our report provides a timely prescription for change,? noted Sheridan Scott, Commissioner of Competition. ?Our study suggests ways to make the generic drug market work better for consumers, businesses, and governments, so we can all get the most value for our health care dollars.?

Data Exclusivity Period Could Be Cut by Half

An analysis by a former senior advisor to the House Ways and Means Committee has found that 7 years is enough time to grant biologics manufacturers before biogenerics can come to market, rather than the 14 years currently supported by the Biotechnology Industry Organization.

The study by Alex Brill, currently a research fellow at the American Enterprise Institute, was commissioned by Teva Pharmaceuticals USA. ?Alex Brill?s findings inject a new and much-needed perspective on the debate around data exclusivity and biogenerics,? said William Merth, president and chief executive officer of Teva North America. ?This work underscores the importance of finding the balance needed to appropriately reward biologics innovators while maximizing health care savings.?

. . . And European Commissioner Wants More Competition

Neelie Kroes, the European Commissioner for Competition Policy, says that competition in the pharmaceutical sector does not work as well as it should.

In releasing a preliminary report on the subject in November, she identified 3 practices most responsible for delaying or blocking market entry of competitors: patent clustering, a large number of litigation cases over patents; and patent settlements that constrain market entry of generic companies.

The report also notes that in 1 year following entry by generic medicines, prices are almost 20% lower, and 25% lower after 2 years; in a rare number of cases, prices can drop as much as 80% to 90%.

The final report is expected this spring.

Follow-on Biologics Focus of FTC Roundtable

The Federal Trade Commission (FTC) recently hosted a roundtable discussion to address issues of competition and continued innovation under a framework for follow-on biologic drugs, a move many stakeholders see as evidence of growing momentum to establish a pathway for biogenerics.

Panelists on the roundtable included representatives of the FDA, insurers, generic and brand name drug manufacturers, and academia, among others.

?Increased competition in the biologics market will benefit health plans, employers, and federal programs, and more importantly, will help make specialty medicines more affordable for patients, many of whom must take these medicines their entire lives,? said Dave Golding, RPh, executive vice president for specialty pharmacy services at CVS Caremark, and one of the roundtable participants. ?We support the creation of a federal legislative pathway for FDA approval of these medicines to provide access and savings to patients and payers.?

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