FDA Announces Public Hearing on Abbreviated Approval Process for Biologic Products

The Biologics Price Competition and Innovation Act of 2009 (“the Act”), which is included in the Patient Protection and Affordable Care Act signed into law on March 23, 2010, provides an abbreviated regulatory approval pathway for biologic products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. The objectives of the Act are similar to those of the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act), which provides an abbreviated pathway for the regulatory approval of small molecule drugs. However, the implementation of the abbreviated approval process for biologics by the Food and Drug Administration (FDA) will necessarily differ due to the complexity of biologic products and their methods of production as compared to small molecule drugs.

The Act provides for abbreviated approval of biological products as biosimilar or interchangeable. As set forth in the Act, a product may be shown to be biosimilar to a reference product based upon studies demonstrating that it is “highly similar” to the reference product and that there are no “clinically meaningful differences” in terms of safety, purity and potency. A product may be determined to be interchangeable with the reference product if it is biosimilar to the reference product, can be expected to produce the same clinical result in a given patient, and if the risk, in terms of safety and efficacy, of switching between use of the biologic product and reference product is not greater than the risk of using the reference product without such switch. Products that meet the higher standard of interchangeability may be substituted for the reference product by a pharmacist without the intervention of the prescribing healthcare provider.

The Act does not provide any further clarification of the terms biosimilar and interchangeable, nor does it define “highly similar” or “clinically meaningful differences.” It provides little guidance on the specifics of the review process, and permits, but does not require, the FDA to issue general or specific guidance after the opportunity for public comment. The Act also requires the FDA to develop recommendations to present to Congress with respect to a user fee program.

After the law was signed, the FDA established a working group, the Biosimilar Implementation Committee (BIC), to plan an approach to implementation. The BIC reported that it was addressing issues including resource evaluation, policy development and budgetary planning, and that it intended to hold public hearings to solicit comments from members of the public.

On October 5, 2010, the FDA announced the much anticipated hearing in the Federal Register. 75 Fed. Reg. 61497 (Oct. 5, 2010).  In the notice, the agency stated that the Act is consistent with its policy of permitting reliance on information that is already known about a drug, but acknowledged that implementation of the approval pathway “can pose scientific and technical challenges associated with the larger molecular structure and manufacturing of biological products” relative to small molecule drugs.

The FDA has requested comments from interested stakeholders on a number of specific questions, as well as any issues related to biosimilar and interchangeable biological products. The public hearing will be held at the FDA’s White Oak campus in Silver Spring, Maryland on November 2 and 3, 2010, and will also be webcast. The FDA will accept electronic and written comments until December 31, 2010.

This article was written by Janet MacLeod, Ph.D., Esq.

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