Biologics don't need long market exclusivity, FTC says

But a generic biologics pathway bill that would grant at least 12 years of protection continues to attract co-sponsors.

By Doug Trapp — Posted June 29, 2009

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A recent Federal Trade Commission report asserting that original biopharmaceutical drug manufacturers do not need lengthy exclusive marketing periods to maintain innovation has not driven supporters from a bill that would extend such protection.

The FTC concluded in a June 10 report that giving original manufacturers of biologic drugs 12 or more years of exclusive marketing would not be necessary because existing patent protections should suffice. The commission said the difficulty of producing, obtaining approval for and marketing generic biologics -- often called biosimilars or follow-ons -- will naturally limit their ability to compete with original biologic drugs. The 120-page report is based on input from dozens of drug companies, university researchers, and others.

Expectations are high that Congress for the first time will adopt an approval pathway for generic biologics this year as part of national health reform legislation, increasing access to an otherwise expensive class of drugs. Breast cancer medication Herceptin, for example, can cost $48,000 annually, according to the FTC report. More than $40 billion was spent on original biologics in 2007, according to medical data firm IMS Health. President Obama's 2010 budget request estimated that creating a generic biologics pathway would save the system $6.3 billion over a decade.

"If Congress creates an efficient pathway to follow-on biologic drugs ... it will be taking a major step forward for both health care reform and affordable drugs for all Americans," said FTC Chair Jon Leibowitz. No standard approval process exists for generic biologics in the U.S.

However, at this article's deadline, none of the five congressional committees with jurisdiction over health care had introduced reform bills with a pathway for generic biologics.

An aide for Rep. Anna Eshoo (D, Calif.), the sponsor of a pathway bill that would provide at least 12 years of market exclusivity, said Eshoo was unconvinced by the commission report. "She doesn't really count on the FTC as really being an expert on issues related to drugs and biotechnology," said the aide, speaking on condition of anonymity in order to discuss the issue openly. However, the commission does examine drug company mergers and cases in which brand-name manufacturers have attempted to delay generic competition.

The Biotechnology Industry Organization characterized the FTC report as fundamentally flawed. For example, it notes the report discounts the advantage generic biologic drugmakers will have by being able to rely on the original manufacturers' research and development. "The report appears to minimize greatly the impact on innovation that would occur," said BIO spokesman Jeff Joseph.

The FTC report has not decreased support for Eshoo's bill, the Pathway for Biosimilars Act. The measure had 104 co-sponsors at this article's deadline, including 12 who signed on since the commission released its report. In contrast, a bill sponsored by House Energy and Commerce Committee Chair Henry Waxman (D, Calif.) that would provide a minimum of only five years of market exclusivity to original manufacturers has attracted only 12 co-sponsors, including one since the FTC report was released.

Sen. Edward Kennedy (D, Mass.) has not reintroduced his generic biologics pathway legislation from last year, which also would allow at least 12 years of exclusive marketing. Kennedy, chair of the Senate Health, Education, Labor and Pensions Committee, has frequently been absent from the Capitol to receive treatment for brain cancer.

Generic Pharmaceutical Assn. President and CEO Kathleen Jaeger praised the FTC report for dismissing the same arguments that were used against the Hatch-Waxman Act, which created a pathway for generic chemical drugs in 1984.

American Medical Association policy supports the development of an approval pathway for generic biologics. However, it says such a pathway should not compel physicians to consider generic biologics as interchangeable, or therapeutically equivalent to the original. It should allow the Food and Drug Administration to require clinical trials for generic biologics but should prohibit the FDA from approving generics with differences in efficacy and safety from the original drug, the AMA says.

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Biologic drug debate

The Federal Trade Commission on June 10 released a report concluding that generic versions of biopharmaceuticals -- made from living cells and proteins -- will be more difficult and costly to produce than generic versions of traditional, small-molecule drugs. The report is based on input from drug manufacturers, law firms and university researchers. It concludes that:

  • Manufacturers of original biologic drugs do not need the 12 to 14 years of exclusive marketing called for by groups such as the Biotechnology Industry Organization because the original biologic drugs likely will keep most of their market share. New biologic drugs should receive adequate protection through manufacturing technique patents, among other patents.
  • Generic biologics are likely to offer savings of only 10% to 30% against the original biologic drug in part because they are more difficult to substitute for the original drug and because the original biologic manufacturers likely will cut prices.
  • Competition between generic and original biologics is more likely to resemble brand-to-brand competition than the generic-to-brand competition of traditional drugs. For example, some original biologic manufacturers are likely to produce generic biologics for markets in which they haven't yet competed.

Source: Federal Trade Commission, June (link)

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