BioCentury reports:
“Proponents of six separate bills seeking to create a pathway for approval of biosimilars are trying to line up enough support to prevail in a vote that could come as early as Friday in the Senate Health, Education, Pensions and Labor (HELP) Committee. The bills have been introduced as amendments to healthcare reform legislation.
The Biotechnology Industry Organization is strongly backing an amendment introduced on Thursday by Sens. Kay Hagan (D-N.C.), Michael Enzi (R-Wyo.) and Orrin Hatch (R-Utah) that would provide 12 years of exclusivity for pioneer biologics. BIO is opposing an amendment introduced on Tuesday by committee Chairman Sen. Edward Kennedy (D-Mass.), arguing that the amendment's nine year period of guaranteed exclusivity is too short. BIO also opposes language that seeks to limit exclusivity to a "major new substance" that would exclude many biologics, as well as the amendment's limited exclusivity for products approved before enactment of the legislation.
Sen. Sherrod Brown (D-Ohio) has introduced two biosimilars amendments, which would provide for seven and nine years of exclusivity. Two other pending amendments, filed by Sens. Barbara Mikulski (D-Md.) and John McCain (R-Ariz.), would provide 10 years of basic exclusivity. If the HELP Committee fails to agree on one of the amendments, it may send healthcare reform to the Senate floor without biosimilars provisions. This could put the creation of a biosimilars pathway in the hands of the House of Representatives.”
On a related note, it seems that BIO needs to hire a new publicist for Jim Greenwood. In her Wall Street Journal article, reporter Alicia Mundy refers to him simply as an “industry lobbyist.” I guess the fact that he’s the president of BIO and a former United States Congressman isn’t relevant. It’s also interesting that she describes the Kennedy bill as a “victory” for biotech.
Ms. Mundy should probably put Steve Usdin on speed dial.
