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The Generic Biologics Debate Moves to the Senate


On March 26, 2009, Senator Charles Schumer (D-NY) introduced S. 726, the Promoting Innovation and Access to Life-Saving Medicine Act. Virtually identical to H.R. 1427, introduced by Congressman Henry Waxman (D-CA) on March 11, 2009, the Schumer bill would create an abbreviated process for the Food and Drug Administration ("FDA") to approve generic biological drugs. The bill is co-sponsored by Senators Susan Collins (R-ME), Sherrod Brown (D-OH), Mel Martinez (R-FL), Debbie Stabenow (D-MI), and David Vitter (R-LA).

Like H.R. 1427, the Schumer bill differs significantly from H.R. 1548, a bill introduced on March 17, 2009 by Reps. Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton (R-TX). To facilitate comparison of the bills, the following chart summarizes each of the key provisions of each.


Data Exclusivity:

Up to 6 years of data exclusivity.

Data Exclusivity:

Up to 14.5 years of data exclusivity.

Product Names:

Biosimilar products must carry the same name as the original products.

Product Names:

Biosimilar products must have unique names.

Product Interchangeability:

A generic biologic applicant may establish that a product is "interchangeable" with the originally approved product. If the FDA agrees, the generic biologic drug could be substituted for the approved product, subject to state law requirements. The FDA would have discretion to determine what clinical studies would be required to establish safety, efficacy and interchangeability, and to require post-market studies.


A generic biologic applicant may establish that a product is "biosimilar." Analytical studies must demonstrate that the product is highly similar, animal studies on toxicity, and clinical studies on safety (including immunogenicity), purity, and potency. With the exception of immunogenicity, these studies can be waived by the FDA. Waiver of immunogenicity requires publication of final guidance regarding requirements for immunogenicity by the Secretary of Health and Human Services after public comment.

Exclusivity for First Generic Approved:

The first applicant to demonstrate interchangeability would receive 180 days of marketing exclusivity.

Exclusivity for First Generic Approved:

The first applicant to gain approval of an interchangeable product would receive up to 24 months of marketing exclusivity.

Clinical Trials:

Not required.

Clinical Trials:

Biosimilar makers must conduct clinical trials for immunogenicity on their products.

Patent Infringement:

A biosimilar applicant may send the holder of the approval for the referenced product a request for patent information. The approval holder would then be required to provide a list of patents that relate to the product within 60 days. The applicant could provide notice to the approval holder, the patent owner, and the Federal Trade Commission of the factual and legal bases for a belief that one or more of the patents are invalid, unenforceable or would not be infringed by the commercial sale of the product for which approval is sought. The applicant would not be required, and could not be compelled, to send the request for patent information or the notice. Within 45 days of receipt of the notice, the holder of the approved application or the patent owner could bring an action for infringement. If a patent is not timely disclosed in response to a request for patent information, the patent owner or licensee would be precluded from bringing an action for infringement of the patent.

Patent Infringement:

A biosimilar applicant must provide the reference product sponsor with a copy of the application within 30 days of acceptance of the application. The reference product sponsor must in turn provide the applicant with a list of relevant patents owned by the reference product sponsor within 60 days of receipt of the application from the biosimilar applicant. The applicant must then respond to the list of relevant patents within 45 days by either stating the applicant will not commence marketing the biosimilar product, or by explaining why the proposed product would not infringe on the sponsor's patents or why the patents are invalid or unenforceable. If the sponsor brings an action for infringement concerning a relevant patent within 60 days of the applicant's response to the list of valid patents, and a court determines the application would infringe the patent, then approval of the application is effective after the valid patent expires.

There seems to be a consensus that legislation in some form will be enacted this year, but only after considerable negotiation and compromise. In recent months, President Obama has expressed support for legislation that would expedite the FDA approval process for generic biological products. The President estimates generic biotechnology drugs could yield $9.2 billion in savings to the federal government over 10 years, and argues that this savings can be used to finance health care reform. These arguments have been met with concern by some Republicans who vowed that a bill creating an abbreviated approval process for generic biological products will never get passed by Congress. Currently, the major point of contention is the length of the period of data or market exclusivity.

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