States that economic evidence does not support any exclusivity period for pioneer biologics

The Federal Trade Commission (FTC) today released its long-awaited report detailing its findings and recommendations with respect to competition in the anticipated Follow-On Biologics (FOB), or biosimilars, market. FOB's are akin to generic pharmaceuticals or small-molecule drugs.

Stakeholders expect that Congress will rely heavily on the 120-page report, entitled Emerging Health Care Issues: Follow-on Biologic Drug Competition, as it considers health care reform and competing bills to provide a regulatory pathway for the introduction of FOB products into the U.S. market. The report's major findings are set forth below.

  • A pioneer or brand biologic is unlikely to suffer the same significant price and market share erosion upon the entry of an FOB compared with what occurs in brand-generic competition under Hatch-Waxman.
  • Because FOB competition with a pioneer biologic drug is likely to resemble brand-to-brand competition among biologics, the FTC believes that provisions that delay FOB entry and restrict competition will likely harm consumers. For example, the FTC rejects the need for:
    • Awarding any period of branded exclusivity (also referred to as data or market exclusivity) in addition to already available patent protection;
    • Special procedures to resolve patent disputes prior to FOB launch; and
    • A marketing exclusivity period for the first generic applicant.

In the coming days, we will provide a more comprehensive review of this Report and an analysis of its potential impact on the pending legislation. Tomorrow, June 11, the Health Subcommittee (Chairman Pallone, D-N.J.) of House Energy and Commerce Committee will hold a hearing on the report, which observers believe will offer a preview of how the report will be used in the legislative battles over H.R. 1427, titled the “Promoting Innovation and Access to Life-Saving Medicine Act,” (H.R. 1427) which is co-sponsored by Rep. Pallone and Rep. Henry Waxman (D-Cal.), among others and the "Pathway for Biosimilars Act" (H.R. 1548) which is co-sponsored by Anna G. Eshoo (D-Cal.), Jay Inslee (D-WA), and Joe Barton (R-TX). Additionally, Sen. Kennedy (D-MA) included a place-holder for FOBs in his health care reform legislation.