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May 07, 2007
 |  BioCentury  |  Politics, Policy & Law

Biodissimilars

Extended discussion about follow-on biologics in both houses of Congress last week made it perfectly clear that there is unanimity regarding the wisdom of creating a pathway for FOBs. But there is nearly complete disagreement about how to go about it.

It is clear the only way FOBs legislation will be enacted by the 110th Congress is if it is perceived as protecting the interests of innovators, as senators and representatives who strongly favor the interests of generic drug companies are finding themselves unable to advance their biogenerics proposals.

The divergence of FOB policy prescriptions was on display on the floor of the Senate, and at a House Energy and Commerce Committee health subcommittee hearing on "Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States."

In the Senate, a bipartisan quintet engaged in a colloquy about FOBs during debate on the FDA Revitalization Act (S. 1082), the PDUFA reauthorization bill. They were in harmony regarding the importance of passing FOB legislation this year, but acknowledged that they could not agree on the basic principles.

In the House, Rep. Henry Waxman (D-Calif.) defended his pro-generics bill, the Access to Life-Saving Medicine Act (H.R. 1038/S. 623), which would create a rapid approval system for FOBs and includes no incentives for innovators. But the discussion demonstrated that Waxman doesn't have enough votes to get the bill passed by the Energy and Commerce Committee without major revision (see BioCentury, April 9).

A number of representatives, including Anna Eshoo (D-Calif.) and Jay Inslee (D-Wash.), emphasized the differences between biologics and small molecule drugs and argued Waxman's approach would create disincentives to biomedical progress.

Inslee is the co-sponsor of a different FOB bill at the other end of the spectrum, the Patient Protection and Innovative Biologic Medicines Act (H.R. 1956). It seeks to create a Byzantine FOB approval process that would take many years for sponsors to navigate.

H.R. 1956 is closely modeled on legislative specifications that Amgen Inc. (AMGN, Thousand Oaks, Calif.) provided members of Congress last year. This bill, too, lacks...

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