Competitive Enterprise Institute Report Makes the Case for BioGenerics; House Mulls Competing BioGeneric Legislation

May 31, 2007

On May 22, 2007, the Competitive Enterprise Institute (“CEI”), a self-described non-profit public policy organization dedicated to advancing the principles of free enterprise and limited government, published a report, titled “Healthy Competition: The Case for Generic and Follow-On Biologics.”  The report, authored by Gregory Conko, states:

[M]any groups have sought the creation of a new abbreviated regulatory pathway for generic—or what the FDA calls “follow-on”—biopharmaceuticals.  It may be possible for FDA to establish such an abbreviated approval process on its own, and the agency’s initial attempt to create such a process for generic conventional drugs may serve as a useful model. That effort was frustrated, however, by a variety of inefficiencies, so new statutory authority is probably necessary to make the approval process for follow-on biopharmaceuticals efficient and effective. . . .  [Some] observers note that, because the research and development costs for biopharmaceuticals are significantly greater than for conventional drugs, and because the biotechnology industry is considerably less mature, Congress should enact special provisions—such as additional patent life or data exclusivity protections—that will help the industry remain viable. Indeed, Congress should consider certain limited incentives for innovation. However, once the patent and data exclusivity protections expire, there should be a simple and proficient method for getting approval of follow-on biopharmaceuticals.

The report also cites several FDA drug approval actions, including the Agency’s May 2006 approval of a 505(b)(2) application for OMNITROPE (somatropin [rDNA origin]) for injection, as an indication that “FDA has begun to reconsider the ‘process is the product’ philosophy that has governed biologics regulation since 1902 —at least so far as small and relatively well-characterized protein products are concerned.”  Indeed, FDA has been departing from the “process is the product” philosophy ever since the mid 1990s when the Agency accepted “bioequivalence data” to compare the monoclonal antibody produced at an original manufacturing site to the monoclonal antibody submitted to FDA as VERLUMA (nofetumomab). This change was further signaled in 1996 when FDA issued its comparability guidance document, “Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products,” which permits reliance on clinical data from a “precursor product” if there is evidence of comparability.

Meanwhile, the U.S. House of Representatives is considering two competing bills that would create a biogeneric approval pathway.  The first bill, H.R. 1038 (“Access to Life-Saving Medicine Act”), was introduced by Rep. Henry Waxman (D-CA) earlier this year, and is generally backed by supporters of generic biologics.  The bill would amend the Public Health Service Act (“PHS Act”) to authorize FDA to approve applications for products that are “comparable” to and “interchangeable” with an innovator product.  A generic applicant may elect to establish that its product can be substituted for the innovator product.  To encourage the development of interchangeable products, the first generic applicant to obtain approval would be awarded a 180-day exclusivity period during which no other interchangeable version may be approved.  However, FDA may approve a comparable version if the product has not been shown to be interchangeable.

The second bill, H.R. 1956 (“Patient Protection and Innovative Biologic Medicines Act of 2007”), was introduced by Rep. Jay Inslee (D-WA) in April 2007.  The bill would, among other things, amend the PHS Act to authorize FDA to approve “similar biological products,” but would prevent interchangeability.  In addition, the bill would provide marking exclusivity to innovator drug companies.


Categories: Hatch-Waxman