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Mark Armstrong Quoted in Article, "FDA Issues Biosimilars Draft Guidance; Some Issues Are Open to Interpretation"

Specialty Pharmacy News, 3/9/2012

Mark Armstrong, a Member of the Firm in the Health Care and Life Science practice, in the Houston office, was quoted in an article titled "FDA Issues Biosimilars Draft Guidance; Some Issues Are Open to Interpretation."

Following is an excerpt:

In terms of studies required, the guidance does not specify "which test or tests may be required for which biosimilar product," attorney Mark Armstrong points out.

"It is realistic that the FDA acknowledges that this is a work in progress," says Armstrong. "Future experiences will help guide and shape what the FDA is going to do."

Manufacturers of biosimilar drugs, says Armstrong, will "need to make a decision on which pathway they should take" — the newer abbreviated pathway or the traditional BLA. "Are there significant advantages to going the biosimilar route?"

"There is still some analysis that needs conducted to determine the predictability of approval," Armstrong tells SPN. "Everybody wants predictability of approval."

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