High Court must fix misguided ruling delaying availability of cost-saving biosimilars
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Biologic medications (“biologics”) have been described as miraculous given their potential to help patients suffering from a myriad of serious diseases in ways more traditional small molecule medicines cannot. These therapeutics provide the ability to treat many complex and life-threatening disorders including diabetes, rheumatoid arthritis, multiple sclerosis and a variety of cancers, and have become some of the most widely prescribed drugs. In fact, seven of the world’s top 10 selling drugs in 2015 were biologics. 

But biologics are expensive, costing on average 22 times more than traditional small-molecule medications. Indeed, drug spending for biologics accounts for 28 percent of all prescription drug spending, with both use and cost expected to grow.

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Within this context, the advent of biosimilars offers hope. These drugs – safe, effective and more affordable alternatives to costly brand biologics – can help increase access and reduce costs to these powerful medicines. The Federal Trade Commission (FTC) estimates that biosimilars will cost approximately 30 percent less than brand biologic drugs, and industry estimates suggest competition between brand biologic products and biosimilars could save American taxpayers overall, including the federal government, as much as $250 billion by 2024. Of note is the experience globally.  The use of biosimilars in territories like the EU, for example, has afforded millions of patients access to these important medications, with billions of euros being saved. 

But in order to fulfill the promise of biosimilars within the US, we must create a sound environment that applauds innovation while encouraging competition. 

In 2010, Congress enacted the Biologics Price and Competition and Innovation Act (“BPCIA”), an expedited pathway for biosimilar approvals. Six years later, only a singular biosimilar is available to patients, a woeful situation for patients requiring biologics, and a reflection on the inadequacy of support for biosimilars.

Today, we face a situation where these medications continue to be outside the reach of patients and providers, and where the need for biologic medications can force a patient to have to make a decision between getting therapy and needing to file for bankruptcy.  In this context, the BPCIA seeks to carefully balance innovation and competition, including a framework for the efficient resolution of patent disputes between the brand manufacturer and a biosimilar applicant. Regretfully, in an attempt to maintain both the status quo and market share, some branded companies have exploited an apparent ambiguity in the BPCIA’s text to create a market exclusivity through the courts that exceeds congressional intent, resulting in biosimilars being unavailable to patients for even longer periods. This has resulted in biosimilar manufacturers being required to wait an additional six months following FDA drug approval to access these affordable, life-saving medicines, and is effectively a court-created marketing exclusivity beyond the guaranteed 12-year period of exclusivity a brand biologic already enjoys by statute.

The lower courts’ misreading of the BPCIA represents a massive windfall to brand pharma and undoes a carefully negotiated congressional compromise that will substantially increase healthcare costs for Americans and for the American government.

Two biosimilar applicants directly impacted by these rulings have petitioned for Supreme Court review. While the two manufacturers took different approaches to settling patent disputes under the BPCIA, both were forced by the courts to wait an additional six months before marketing their products. The petitioners make the powerful argument that the BPCIA does not require a biosimilar applicant to give a notice of commercial marketing on the approval date, causing the unnecessary six-month marketing delay. Congress intended exclusivity of these biologic medications for 12 years, not 12 ½ years.

It is vital that the Supreme Court take up these petitions and rectify the lower court’s fundamental misreading of the BPCIA in order to facilitate the development of an essential and robust biosimilars market. An extension of the marketing exclusivity period will impede access to biosimilars and add hundreds of billions of dollars in costs to patients, payers and the health care system at large, including programs like Medicare and Medicaid. With drug prices rising at unaffordable rates, society in general and patients in particular cannot afford the price tag imposed by such misguided rulings.

Bert Liang, M.D., Ph.D., M.B.A, is Chairman of Biosimilars Council and CEO of Pfenex Inc.


The views expressed by authors are their own and not the views of The Hill.