The Food and Drug Administration has scheduled a two-day public hearing next week on regulations for the approval of biosimilars, which are generic equivalents of biologics.

The health care reform law signed by President Barack Obama last March calls for a shortened approval process for biological products that are biosimilar to, or interchangeable with, an FDA-licensed biologic. Biologics include many of the latest therapies for serious illnesses, such as cancer and related therapies, so the aim is to widen their availability. The law allows for approval of biosimilars after 12 years of market exclusivity for the original biologic product.

The FDA states that the purpose of the November 2-3 hearing is to create a forum for interested stakeholders to provide input on establishing the regulations. For more information on the hearing, click here.

Biologics are the future of drug development. Biosimilars, which are generic equivalents of biologics, are starting a new paradigm of patent and regulatory control.

Unlike drugs, which are generally chemically definable, biologics may be defined by the production process and the molecule itself. They are generally produced using living systems, which result in a composition that contains the therapeutic molecule in addition to many “contaminants.” As a result, designing a pathway to approval for biosimilars presents an enormous challenge.

Patient safety and patent protection, critical to fostering innovation, may present the highest hurdles to laying a regulatory path. Both are potentially threatened by the approval of biosimilars—because biologics are unique. Unlike in the case of generic drugs, a biosimilar is similar to but not the same as the original biologic molecule.

Most biologics are produced in a living system, so the cells involved are vulnerable to changes in environment, cell types, or media components. Such vulnerability can result in a shift in the makeup of the resulting product—and in its safety. The critical role of the process of making biologic molecules makes protection of the innovator’s or biosimilar applicant’s data a significant concern.

In establishing the pathway for regulating biosimilars, the FDA will need to figure out how to ensure that a biosimilar resembles its innovator closely enough so that the biosimilar has the efficacy and safety like those of the original biologic; how to protect patients from unintended consequences, such as new or adverse immune responses to a biosimilar; and how to implement the patent infringement and invalidity issues inherent in marketing biosimilars.

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