When the Supreme Court upheld the constitutionality of the Patient Protection and Affordable Care Act, those hoping to benefit from the portion of the law known as the Biologics Price Competition and Innovation Act (the "Biologics Act") may have breathed a sigh of relief. However, the Biologics Act is not out of the woods, because Abbott recently filed a Citizen Petition with the FDA, seeking to block its implementation of the law as unconstitutional.
The Biologics Act
The Biologics Act creates a path to market entry for biological products that is similar to (but substantially different from) the path provided to small molecule drugs by the Drug Price Competition and Patent Term Restoration Act of 1984 (generally known as the "Hatch-Waxman Act"). (A copy of the law is available through the FDA's Biosimilars webpage.) Key differences in the regulatory approval provisions of the Biologics Act reflect the complex nature of biologics and the safety and efficacy concerns surrounding biological products that may not be chemically identical to the approved reference product. The Biologics Act also has a completely different mechanism for treating patent issues than those set forth in the Hatch-Waxman Act. ( This article provides a more detailed discussion of the Biologics Act.)
Like the Hatch-Waxman Act, the Biosimilars Act arose from a desire to facilitate market entry of lower-cost "generic" versions of biological drugs. For example, at the Biosimilars 2007 Conference, Representative Henry Waxman remarked that "biotech drugs are the future of medicine." In 2006, the last year for which data is available, biotech sales grew by 20% to $40.3 billion, while sales of traditional, small molecule pharmaceuticals increased by only 8%. With skyrocketing pharmaceutical costs and increased consumer demand, lower-cost alternatives are understandably a priority. However, the demand for "generic" versions of biologics must not take precedence over the need to ensure the safety and efficacy of approved pharmaceutical products and must be balanced against the need for sufficient market exclusivity for innovator products to incentivize continued research and development.
The Biologics Act attempts to balance these competing interests by providing timeframes of exclusivity to innovator (reference) biologic drug products. For example, an application for FDA approval of a biosimilar product can be filed four years after approval of the reference product, but the application may not be approved until 12 years after approval of the reference product. (Approval of a biosimilar may be further delayed if patent infringement claims are still pending.)
Abbott's Citizen Petition
Abbott Laboratories filed a Citizen Petition with the FDA on April 2, 2012, asserting that if the FDA approves a biosimilar of its Humira® product under the Biologics Act, the agency will be engaging in an unconstitutional taking of the company's intellectual property. Specifically, Abbott argues that much of the analytical, preclinical, clinical, and manufacturing data and information from Abbott's extensive testing and development of Humira® is eligible for trade secret protection and may not be relied upon by the FDA to support a biosimilar application of a third party. Abbott asks that the FDA not consider any application that cites Humira® as a reference product. (Abbott's main patent on Humira® is set to expire in December 2016).
Abbott's petition follows that of Genentech filed in 2004. Genentech asserted that the agency should not even issue a guidance document relating to the data requirements for biosimilar applications, since such guidance would benefit from knowledge gleaned from patentees such as Genentech. The FDA ultimately denied the Genentech petition, stating that the guidance did not "violate any protections available to applicants by relying, either 'directly or indirectly,' on Genentech's or any other entity's confidential information. . . [,] [did] not disclose any trade secret or confidential information, and [that] FDA did not impermissibly use or rely upon any such information in developing them." (See this article for an overview of the FDA's draft guidance document.) Abbott's petition raises a harder question, because a biosimilar application would, by definition, rely upon the data supplied by the reference sponsor.
A Long Road Ahead
It is likely that the issues raised in Abbott's Citizen Petition ultimately will have to be decided by the courts. The final outcome could impact the viability of the biosimilar framework, and have far-reaching effects on the biotechnology industry, as well as on healthcare costs and patient care. As the U.S. struggles with these issues, it is interesting to watch how they have played out in other countries. For example, the European Union's EMA has had a biosimilar approval process since 2003, and fourteen biosimilar products have been approved to date. While parties on either side of the Patient Protection and Affordable Care Act debate whether we should have a European-style healthcare system, parties on either side of the Biologics Act may debate whether we should have an EMA-type biosimilars system.
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