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Pathway for Biosimilars Act Protects Patients, Promotes Competition, Preserves Innovation and Creates Quality Jobs, Lilly Says
Date:3/17/2009

INDIANAPOLIS, March 17 /PRNewswire-FirstCall/ -- Today Eli Lilly and Company (NYSE: LLY) announced its support for the Pathway for Biosimilars Act. The U.S. has a 25-year history of success with laws promoting the discovery of new, chemical-based medicines and providing an abbreviated approval process under which generic versions of those new medicines can to come to market. But Congress has yet to take that step with the most advanced new medicines, called biological drugs or simply "biologics."

Lilly said the Pathway for Biosimilars Act, reintroduced in the 111th Congress by Reps. Anna Eshoo (D-Calif.), Jay Inslee (D-Wash.) and Joe Barton (R-Texas), would successfully create a pathway that carefully weighs the needs of patients and stakeholder companies. This balance, Lilly said, would assure patients and payers the benefits that come from greater competition, preserve incentives for biotechnology innovation and foster investments that will produce more high-paying jobs in the life sciences.

"Lilly commends Representatives Eshoo, Inslee and Barton for joining together and introducing a carefully considered, balanced approach to ensuring the promise of biotech medicine becomes a reality for patients," said Robert Armitage, Lilly's senior vice president and general counsel. "Making biotech discoveries entails many years of research, massive investments and high risk. This bill makes certain that innovator companies can continue to make these types of investments in new therapies for patients, and that, once a reasonable period of time has passed for recouping its investment, generic companies can copy those innovations in a safe, scientifically sound manner."

The key provision of the Eshoo-Inslee-Barton bill striking this balance is the 14-year "data protection period." The legislation's formula would offer al
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