TPP provides 5-plus years of biologics exclusivity

The Trans-Pacific Partnership trade treaty will set a floor of five years of data protection for biologics, U.S. Trade Representative Michael Froman announced Monday. Details of the agreement have not been released. Statements from Froman and Australian Minister for Trade and Investment Andrew Robb stressed the role of regulatory and administrative mechanisms in addition to data exclusivity to delay the market entry of biosimilars, but did not provide details. The TPP was negotiated by 12 countries, including the U.S., Japan and Australia.

TPP will include commitments for administrative and regulatory procedures that will have the effect of extending market exclusivity in countries that adopt the five-year period, Froman said at a press conference. "What we are doing in TPP is recognizing that we are all trying to achieve effective market protection and deliver a comparable outcome through various mechanisms, including at least five years of data protection, plus other government measures that can achieve a comparable outcome," Froman said. ...