Competing Biosimilars Proposed Legislation

On March 11, 2009, Representative Henry Waxman (D-Calif.) sponsored H.R. 1427, titled “Promoting Innovation and Access to Life-Saving Medicine Act,” which would amend the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products.  H.R. 1427 would allow any person to file an abbreviated biological product application with the Secretary of Health and Human Services (Secretary) and require such applications to include information demonstrating a high degree of similarity or interchangeability between the biological product and the licensed biological product.

The bill would requires the Secretary to: (i) approve an application and issue a license for a biosimilar product unless the Secretary finds and informs the applicant that the information in the application fails to demonstrate biosimilarity between the biological product and the reference product or the safety, purity, and potency of the biological product; and (ii) establish requirements for the efficient review, approval, suspension, and revocation of abbreviated biological product applications.

The bill would grants market exclusivity to any biological product that is determined to be interchangeable for five years with a six-month extension for pediatric products and a six-month extension for new indications.

However, on March 17, 2009, Representatives, Anna Eshoo (D-Calif.), Jay Inslee (D-Wash.), and Joe Barton (R-Texas) introduced a competing bill, H.R. 1548 titled the “Pathway for Biosimilars Act,” which largely mirrors H.R. 1427, with exception to the period for market exclusivity.

H.R. 1548 would prohibit the Secretary from making approval of an application until 12 years after the date on which the reference product was first licensed.

While the Eshoo-Inslee-Barton bill gained praise from the biotech and drug industry trade groups, the bill was criticized by the generic drug industry as preventing patients from getting needed medicines in a timely manner.

On March 11, 2009, both bills were referred to the House Judiciary Committee.  H.R. 1548 was also referred to the Committee on Energy and Commerce.  Regardless of whether either bill is passed and if so, which version is enacted remains to be seen.  The one certainty is that Congress has embraced biosimilars as a priority issue.

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