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Jan 29, 2007
 |  BioCentury  |  Politics, Policy & Law

Firing up for FOBs

Generic drug and biotech companies maneuvered behind the scenes last week to drum up high level support for their positions on follow-on biologics legislation. The issue will break out into the daylight soon with the introduction of legislation and an official estimate of the potential cost savings.

The Democratic Party’s ascendancy to majority status in Congress has sparked a flurry of activity on follow-on biologics (FOBs), accelerating efforts to create a legal framework for abbreviated reviews of proteins based on their comparability to approved versions.

Democrats Rep. Henry Waxman of California and New York Sens. Charles Schumer and Hillary Clinton plan to introduce FOB legislation soon, a staff member working on the legislation told BioCentury. Their legislation will be similar to the Access to Life-Saving Medicine Act they introduced in September 2006 (H.R. 6257), in the last days of the 109th Congress. This time, according to the staffer, they expect to have some Republican co-sponsors.

H.R. 6257 was tailor-made for the generics industry, for example, by limiting the recourse of innovators to sue for infringement, requiring disclosure of new patents and limiting FDA’s discretion to defer or deny approval of comparable biologics (see BioCentury, Oct. 2, 2006,& Online Links, A7).

BIO and FDA plan to release documents soon that could influence the debate, but a report produced by the Congressional Budget Office will have a much larger impact on the fate of FOB legislation in the 110th Congress.

FOBs could rocket to a top-tier legislative issue if the CBO determines that competition for off-patent biologics will save the government substantial sums through lower outlays for Medicare, Medicaid or other programs. The ability to use these savings to fill in the Medicare Part D "donut hole" or to expand the State Children’s Healthcare Insurance Program (SCHIP) could be a compelling motivation to resolve the complex medical, scientific and legal issues associated with FOBs.

On the other hand, a low CBO score could persuade the Democrats to move FOBs off the launch pad.

BIO and Amgen Inc. (AMGN, Thousand Oaks, Calif.) have increased the intensity of their advocacy on FOBs. They are counseling Congress to move slowly and emphasizing that any FOB pathway should not allow automatic substitutability of comparable and reference biologics.

Substitutability is critical to the economics of FOBs. Experience with biologics such as insulin and human growth hormone demonstrates that in the absence of therapeutic interchangeability, the existence of multiple competing products may not result in major pricing competition.

The industry is also starting to drop hints about possible trade-offs for the establishment of an FOB legal framework. It would seek market exclusivity for pioneer biologics, probably for a longer period than is now provided by the Hatch-Waxman Act for new drugs.

Rallying for FOBs

Generic drug and biotech companies have been...

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