U.S. Failing To Seize Biosimilar Opportunity

Apr 21, 2014
Without a clear regulatory path for biosimilars, the U.S. falls behind other countries in improving access and affordability of life-changing medications.

Our country is leaving money on the table when it comes to reining in spending on biologic medications – those used to treat the most chronic, complex conditions.

The U.S., unlike the European Union (EU) and other countries, so far has failed to establish a clear regulatory path to market for biosimilars, the generic counterparts of biologics.

On a recent segment of PBS NewsHour, I shared the implications of the U.S. falling behind other countries in improving access and affordability to life-changing medications:

The Cost Saving Potential of Biosimilars 

Source:  PBS NewsHour

Controlling the Rising Cost of Healthcare

The U.S. spends more on pharmaceuticals than any other developed nation, both per person and as a percentage of our gross domestic product (GDP), a key measure of economic growth. Americans spent $947 on prescription and over-the-counter drugs for every man, woman and child who lived here in 2009 – nearly double the $487 per capita average for countries tracked by the Organization for Economic Cooperation and Development. And that doesn’t include medications consumed in hospitals.

Express Scripts research shows that the U.S. would save $250 billion between 2014 and 2024, with the approval of just 11 biosimilars that are the most likely to be ready for patients in that time frame.

The Need for Clear Regulations

The Patient Protection and Affordable Care Act of 2010 calls for establishing a regulatory path for introducing biosimilars – yet there is no clear guidance from the Food and Drug Administration on how to demonstrate that a product is a biosimilar, other than to say it will be determined on a case-by-case basis.

FDA guidance also is vague on the path for a biosimilar to achieve “interchangeability” status, which would allow it to be substituted for a branded biologic medication.

Express Scripts advocates for the use of generic drugs whenever possible in order to make healthcare more affordable. Today, more than 70% of all drugs dispensed in the U.S. are generics – nearly all of these are traditional, small-molecule drugs rather than biologics. Nevertheless, according to our Drug Trend Report, last year the U.S. spent $53.4 billion unnecessarily on higher-priced medications when more affordable, clinically equivalent generics were available.

Among the hurdles to a clear regulatory path for biosimilars are complaints by branded biologic manufacturers that these drugs, which are made using living organisms rather than by chemical reactions, are so complicated that duplicates may not be as safe and effective as their original products.

Other Countries Moving Ahead

Yet those claims have proven false in other parts of the world.

Biosimilars Map 

In the EU, for example, authorities say biosimilars cost approximately 30% less than their branded counterparts with the same levels of safety and efficacy. Other countries with biosimilars on the market include Canada, Japan, Korea, Australia and India. China has produced biosimilars for domestic use for roughly 20 years and is in the process of drafting regulatory standards in line with the EU so its manufacturers can export to those markets.

And the World Health Organization issued guidelines for biosimilar regulations in 2009, providing a framework that sparked activity in several countries, including Brazil, Argentina, Chile and Mexico.

The U.S., which prides itself on innovation and providing top-notch healthcare, is falling behind in this important area that could improve access and affordability of life-changing medications for patients who most need them.

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