The Biosimilars Debate: Is it Over?

October 7, 2009 by Valerie Gutmann · 3 Comments
Filed under: Biosimilars, Proposed Legislation 

An interesting cell formation observed in this group of cells treated with progesterone and stained with filipin, which is a natually fluorescent antibiotic that binds solely to free cholesterol. Viewed via a phase contrast microscope.

An interesting cell formation observed in this group of cells treated with progesterone and stained with filipin, which is a natually fluorescent antibiotic that binds solely to free cholesterol. Viewed via a phase contrast microscope.

Two months ago, I discussed possible federal legislation intended to balance the competing need for scientific and medical innovation with the costs to patients for biosimilars.  So where does the debate stand now?

Current proposals couple a regulatory approval pathway for biosimilars with exclusivity periods for pioneer biologics.  As part of its July 15, 2009 health reform bill, the Senate Health, Education, Labor, and Pensions (HELP) Committee adopted an amendment proposed by Senators Kay Hagan (D-NC), Michael Enzi (R-WY), and Orrin Hatch (R-UT) that provides for a 12-year exclusivity period for pioneer biologics.   On July 31, despite protestations from Rep. chairman Henry A. Waxman (D-Calif.) that the amendment is “exactly the wrong way” to create a pathway for approval of biologics, the House Energy and Commerce Committee approved H.R. 3200, which also includes a 12-year exclusivity period.

On September 29, ten governors wrote a letter in support of the exclusivity period to House Speaker Nancy Pelosi (D-Calif.), House Minority Leader John Boehner (R-Ohio), Senate Majority Leader Harry Reid (D-Nev.), and Senate Minority Leader Mitch McConnell (R-Ky.), stating, “[i]nnovator companies must be provided with at least 12 years of non-patent data exclusivity to allow for recovery of their original investment and to ensure licensing payments to our research institutions.”

Generic drug makers have, as would be expected, challenged the necessity of longer exclusivity periods.  In a September 24 hearing in front of the House Science and Technology Committee’s Subcommittee on Technology and Innovation, representatives of the generic drug industry argued that confirmatory clinical trials for biosimilars are not necessary and advocated data exclusivity periods of less than 12 years for innovator products.   Of particular concern to potential biosimilar manufacturers is the prospect of “evergreening,” whereby pioneer drug manufacturers will be allowed to tack on multiple exclusivity periods for “minor” modifications.

Waxman had previously proposed a bill that limited the exclusion period to five years and forbade evergreening, and has expressed his intent to continue fighting for a shorter exclusivity period.  The Obama Administration’s proposal (addressed to Rep. Waxman) for the establishment of a new regulatory pathway for FDA approval of biosimilars, includes seven years of exclusivity for pioneer biologics– which it sees as a “generous compromise between what the FTC research has concluded and what the pharmaceutical industry has advocated.”

So the debate is still alive and well.  Proponents of longer exclusivity periods and evergreening for pioneer biologics, like PhRMA and BIO, argue that biologics generally are far more complicated than traditional medicines, and, using current analytical methods, it is difficult to measure the inherent structural differences between pioneer and follow-on biologics, which can affect their safety or effectiveness.  Opponents, like Chris Begly, chairmen and CEO of Hospira, a company that manufactures injectible generic drugs (and the only company to have launched a generic biologic in Europe), contest the Senate and House bills’ endorsement of the 12-year exclusivity period, citing to the AARP’s (as mentioned before, the AARP believes the proposed 12-year exclusivity  is “unreasonable”) finding that manufacturers of many top-selling biologics recoup average research and development costs several times over within the first six years, and often within a single year.

Because the language in H.R. 3200 is not identical to the language in the bill approved by the Senate HELP Committee, further changes to the provisions are still possible in the final health reform legislation.

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Comments

3 Responses to “The Biosimilars Debate: Is it Over?”
  1. Ashritha (infoalcpl@gmail.com) says:
    10/07/2010 at 5:09 am

    My colleagues and I have authored what we believe is India’s first ever complete mapping of the Biosimilars opportunity in India. The report is nowbeing made available to the general public.
    Various issues have been dealt with, such as:
    - Patent expirations
    - Regulatory frameworks
    - Infrastructure Requirements
    - Etc.
    If anyone is interested in this report, please contact me at (infoalcpl AT gmail DOT com), and I would send you the brochure and other details.

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