August 1st, 2009

Letter to the Editor on Exclusivity on Biosimilars

In a letter to the editor in today’s Washington Post, Jay P. Siegel, Chief Biotechnology Officer, Johnson & Johnson, explained his support for longer exclusivity periods for biologics in response to a recent editorial that argued for fewer years of data protection. As Jay described:

“While patents provide protection against identical competitors, they often do not provide protection against variants that could be deemed biosimilar.

In contrast to The Post’s assertion, this situation would leave wiggle room for a biosimilar company to work around patents, allowing competition far sooner than would be possible for traditional generic drugs and thereby failing to maintain adequate incentives for innovation.

Data-exclusivity — the period before a competitor can use an innovator product’s clinical data to gain FDA approval — provides an alternative tool for achieving a fair balance. Data exclusivity of 12 to 14 years for biologics creates parity with the de facto 12 to 14 years of exclusivity before generics are allowed for traditional drugs under the 1984 Hatch-Waxman Act, which has achieved good balance.”

Read the entire letter here

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