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Pathway for Biosimilars Act Protects Patients, Promotes Competition, Preserves Innovation and Creates Quality Jobs, Lilly Says

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 all new biological drugs a base period of 12 years of data protection with the right to obtain an additional two years once a further indication for use of the product is approved by the FDA.

Today, strong patents, when they exist, can protect all types of medicines from competition, including protection from generic copies. However, effective patent protection is sometimes unavailable or available only for a very limited period once a new medicine gets to market. In both these situations, patent protection by itself can be insufficient to secure a fair return on the research investments needed to get the new medicine to market - thus risking the system by which new cures and treatments are found. These and other patent shortcomings are magnified for biological drugs because of their relative complexity and the greater uncertainty in how patent laws will eventually apply to them.

In addition to strong patents, "data protection" would offer additional needed protections for innovative biological medicines. Data protection, unlike patents, sets out a consistent, defined period in which copied versions of a new biological drug can only come to market if it follows the same rigorous testing requirements that the innovator undertook to gain FDA approval.

Thus, through an adequate period of data protection, patients and their physicians can be assured of a more complete safety and effectiveness track record before "follow-on" or biosimilar products come to market - important because of consistency and purity concerns. Significantly, Eshoo-Inslee-Barton's approach to data protection is consistent with the earlier Senate-approved approach.

Armitage noted that the biotech industry that creates life-saving biologic medicines boosts the U.S. economy and provides high-paying American jobs. According to the Bureau of Labor Statistics, the biosciences sector is expected to add 69,000 U.S. manufacturing jobs over the next decade. It already employs some 1.3 million Americans and generates an additional 6.2 million jobs in other industries.

Lilly is the 5th largest biopharmaceutical company in the world, with global biotech sales of more than $5.3 billion in 2008. Today, 40 percent of Lilly's drug pipeline - and 50 percent of its late stage pipeline - is comprised of biotech compounds spanning potential treatment options for diabetes, cancer, Alzheimer's disease, osteoporosis, multiple sclerosis and inflammation.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at


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