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Client Alerts

Fish & Richardson Client Alert: Congress considers competing biosimilars legislation

March 24, 2009

Client Alerts

Fish & Richardson Client Alert: Congress considers competing biosimilars legislation

March 24, 2009

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Congress considers competing biosimilars legislation
Congress considers competing biosimilars legislation
Within the last two weeks, Congressional representatives have introduced two competing bills to enable FDA approval of generic versions ofbiologics. These bills appeared swiftly after President Obama’s 2010 budget specifically called for such a process. Although Congress has considered similar legislation in past years, given the current level of Presidential and bipartisan support, enactment of a generic approval route forbiologics is increasingly likely.Representative Waxman (CA), along with Representatives Deal (GA), Emerson (MO), and Pallone (NJ), introduced the first bill, H.R. 1427 (the “Waxman bill”) on March 11, 2009. On March 17, 2009, Representatives Eshoo (CA), Inslee (WA), and Barton (TX) introduced a competing bill, H.R. 1548 (the “Eshoo bill”).

Generic manufacturers have voiced support for the Waxman bill, while pioneers have come out in favor of the Eshoo bill. Thus, where the Waxman bill proposes a five year exclusivity for pioneers of a new biologic, the Eshoo bill proposes a minimum of twelve years for pioneer exclusivity. Where the Waxman bill seeks to limit the filing of FDA citizen petitions that might delay approval, the Eshoo bill makes the issuance of FDA guidance documents a prerequisite for any generic application. Notably, both proposals contain significant differences from the 1984 Hatch-Waxman legislation which controls the generic approval of small molecule drugs. For example neither bill utilizes the Orange Book and neither includes an express 30 month stay for patent litigation.

To read further, click here.
To view a table comparing the two bills, click here.

Biosimilar Legislation Alert

Fish & Richardson is tracking legislative proposals in Congress concerning biosimilars. We will email you when new information about biosimilar legislation is posted on our web site if you subscribe to our Biosimilar Legislation Alert service. For more information, click here.

© Copyright 2009 Fish & Richardson P.C. These materials may be considered advertising for legal services under the laws and rules of professional conduct of the jurisdictions in which we practice. The material contained in this newsletter has been gathered by the lawyers at Fish & Richardson P.C. for informational purposes only and is not intended to be legal advice. Transmission is not intended to create and receipt does not establish an attorney-client relationship. Legal advice of any nature should be sought from legal counsel. For more information about Fish & Richardson P.C. and our practices, please visit www.fr.com.

 

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