- The Washington Times - Tuesday, September 22, 2009

In the atmosphere of intense partisanship dominating the health care reform debate, developing a policy for biosimilars is one of the few issues to achieve bipartisan support in both the House and Senate. This fact is ignored in the recent Op-Ed written by Chris Begley, the CEO of a biosimilar generic drug manufacturing company (“Opening the door for biogenerics,” Opinion, Friday).

Through strong bipartisan votes, key House and Senate committees have already passed this provision that would allow the U.S. Food and Drug Administration to approve biosimilars, providing a reasonable period of data exclusivity of 12 years. This provision will increase patient access to lifesaving medicines, ensure patient safety and reduce costs while providing a foundation for continued biomedical innovation.

Bringing a new therapy to market can take upwards of $1 billion and require more than 10 years of research, development and testing. If we are to maintain critical momentum in understanding - and overcoming - diseases, policymakers must ensure that incentives for continuing biomedical innovation are intact. Providing innovators with any shorter time period of data exclusivity would eliminate many incentives to innovate.

Key members of Congress have already decided that providing innovators with a period of data exclusivity shorter than 12 years would dampen innovation and fail to provide parity with the Hatch-Waxman construct that currently exists for developers of traditional pharmaceutical drugs.

In a debate where far too many issues have been sidelined by partisan politics, it would be a foolish mistake for Congress to alter dramatically this carefully crafted biosimilars language, which has gained broad bipartisan support along with the backing of dozens of patient groups as well as physician, academic and industry organizations.


Vice president, communications

Biotechnology Industry Organization


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