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

l 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
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SOURCE Eli Lilly and Company
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