Specious Arguments Cloud Biosimilar Regulation

Aug 6, 2013
Express Scripts recognizes the potential for biosimilars, generic alternatives for specialty conditions, to help reduce healthcare costs.

To borrow a phrase from baseball great Yogi Berra, it’s déjà vu all over again.

The branded pharmaceutical industry, concerned with the prospect of lower-cost competition for its specialty medications, is raising barriers to broad commercialization of biosimilar drugs. And its argument closely mirrors the one it used 25 years ago in objection to generic pills.

In 1987, the president of PhRMA, a trade group of biopharmaceutical researchers and biotechnology companies said the following:

FDA standards do not ensure that two versions of a drug deemed equivalent will be equally safe and effective when used interchangeably by patients.

Now fast forward to 2012, and read the talking points issued from BIO, a biotechnology trade association, regarding proposed biosimilars:

This drift in product quality attributes could be enough to be clinically meaningful, i.e., result in a change in efficacy or safety.

Biosimilars Can Reduce Healthcare Cost

Now, as then, Express Scripts and other experts see great potential for lower-cost alternative medications as a tool for reducing healthcare costs, while improving access and affordability to lifesaving treatments for some of the sickest Americans. Generic traditional medications have proven their worth, comprising more than 70% of drugs dispensed in the U.S. today, and are a cornerstone in how we deliver safe, effective and affordable care to millions of people.

Biologic drugs – typically injected to treat chronic and costly conditions such as cancer, multiple sclerosis and rheumatoid arthritis – are made from living organisms in a process that is more complex than producing pills. Biosimilars use the same mechanisms as their branded counterparts for treating disease, but are not identical.

Manufacturers of branded drugs use these facts to argue for very expensive, time-consuming clinical trials of every proposed biosimilar drug. Some also say they should not be automatically substituted for branded biologics, in the manner that generic pills can be switched. These barriers could make it impractical for a company to pursue biosimilars, or impossible for them to dramatically reduce the cost to consumers.

Yet biosimilars are on the market and yielding results in the European Union and other countries, while the U.S. fails to establish a clear regulatory path for their approval.

Branded ‘Biosimilars’ Already on the Market

Ironically, research has shown that, due to the complexity in manufacturing, new batches of some biologic drugs made by branded manufacturers essentially are biosimilars of previous batches. For example, Enbrel (etanercept) in 2010 was found to have a different quality profile than Enbrel in 2009 — but no additional clinical tests or label changes were required.

Changes in the exact cellular makeup of biologic drugs commonly occur when a company changes its manufacturing process to improve efficiency, increase batch size, or move to another site, for example. Even with none of these moves, there is a level of inherent variability in making biologics.

If regulators are satisfied that manufacturing-driven changes in a biologic medication do not alter its safety or efficacy, then they allow the medication to continue to be sold under the existing name and label. And that has been happening for years.

Express Scripts sees great potential for biosimilars to rein in spiraling healthcare costs, since biologic specialty medications are the most expensive and are forecasted to continue their steep upward climb in national drug spend.

It’s time for the healthcare industry and regulators to move past hyperbole and join forces to ensure Americans’ access to the most safe, effective and affordable medications.

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