By
Donald Zuhn –-
In
a statement issued by the Pharmaceutical Research and Manufacturers of America
(PhRMA) earlier today,
the advocacy group representing pharmaceutical and biotechnology research
companies indicated that it "supports the development of a responsible,
abbreviated approval pathway for biosimilars that includes a fair period of
data protection that is critical for the future of medical progress." The group noted that follow-on
biologics legislation currently making its way through the House and Senate
"provides for patient safety and strikes the appropriate balance between
the desire for enhanced competition for biologics, and the need to provide
meaningful incentives for innovation." As reported here previously, the Senate Health, Education,
Labor and Pensions (HELP) Committee approved an amendment in mid-July that
would provide a 12-year data exclusivity period for biologic drug makers (see "Senators Champion 12-Year Data
Exclusivity in Senate"). In late July, the House followed suit
by passing an amendment to its own health care reform bill that would prevent
the FDA from approving a biosimilar application until 12 years after the date
on which the reference product (i.e.,
the innovator biologic) was first licensed. (see "House Committee Approves Health Care Reform Bill Calling
for 12-Year Exclusivity Period").
Arguing
that the complexity of biologics means that "[biologic] patents may cover
just part of the molecule or simply cover the process for its manufacture,"
PhRMA contended that "the nature of patent protection for biologics is
uncertain in the context of biosimilars," and that this uncertainty would
impact investment decisions. The
group envisions that biosimilar manufacturers will be able to use their own
manufacturing processes to create biosimilars differing only slightly from innovator
biologics and possibly "circumvent patents -- while qualifying for an
abbreviated application."
PhRMA warned that "[g]iving short shrift to incentives for
innovation would grind to a halt uniquely American innovation, moving
critically important R&D -- and tens of thousands of U.S jobs –
overseas," and noted that 80% of the world's biotech research currently is
performed in the United States.
The
PhRMA release states that "[e]conomists and the venture capitalists whose
private investments shore up this vital, yet vulnerable sector agree: 12 years of data protection, at a bare
minimum, are needed to help recoup the significant development costs for
biologic innovators."
However, the group also notes that this 12-year period would be for data
exclusivity and not market exclusivity.
Significantly, PhRMA states that "[c]ompanies could still seek
approval of competing biologics using their own data, but for those 12 years no
biosimilar competitor could rely on innovators’ hard–earned data, collected during
development that may span a decade, or more, to seek approval."
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