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PhRMA Statement Supporting Fair Incentives for Biologics Innovation
Date:10/19/2009

WASHINGTON, Oct. 19 /PRNewswire-USNewswire/ -- Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Ken Johnson issued the following statement today regarding appropriate incentives for continued biotechnology innovation:

"PhRMA, along with research universities, patients, healthcare providers, and elected leaders at the state and federal levels, supports the development of a responsible, abbreviated approval pathway for biosimilars that includes a fair period of data protection that is critical for the future of medical progress.

"Legislation moving forward in the U.S. House and Senate provides for patient safety and strikes the appropriate balance between the desire for enhanced competition for biologics, and the need to provide meaningful incentives for innovation.

"Such incentives are vital for ensuring continued development of new biologics that are needed to provide future treatments and cures for such serious ailments as Alzheimer's disease, Parkinson's and cancer. Already, biologic medicines have revolutionized patient care. In fact, these cutting-edge therapies are among the reasons why American patients with life-threatening diseases, like cancer, are living longer.

"The pathway endorsed through strong bipartisan Congressional votes would allow onto the market biosimilars -- medicines that are similar to, but will never be exactly the same as, the original biologic.

"That key element -- similarity -- factors into investment decisions, because the nature of patent protection for biologics is uncertain in the context of biosimilars. Because biologics are extremely complex, patents may cover just part of the molecule or simply cover the process for its manufacture.

"In the future, should this legislation become law, a biosimilar manufacturer using its own manufacturing process to create a biosimilar that differs slightly from an innovator biologic would
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SOURCE Pharmaceutical Research and Manufacturers of America
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