Biosimilars: Much Ado About Nothing, Part 2

By Brittany | March 30, 2012 | Category: Pharmacotherapy
Biosimilars: Much Ado About Nothing, Part 2
By Ralph Tarantino, PhD
Pharmaceutical Consultant and Principal, SteriTech Solutions, LLC
Middletown, NJ

Let’s not forget the reason for the FDA’s existence. The agency was formed to assure the purity of food and drug products (1906). They went on to regulate drug safety (1937) and then drug efficacy (1962). The efficacy regulations were in response to what was truly a safety issue—the use of thalidomide in pregnant women. The FDA is the institutionalized embodiment of the Hippocratic Oath to “first do no harm.” They are cautious because that is their job. Safety does come first. You can always replace a drug that’s not working, but you cannot replace a patient who has died. Suggesting biosimilars could be approved without clinical data is not a very cautious position to take and leads one to wonder about the possible motivation of the FDA in taking that position.

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Biosimilars: Much Ado About Nothing, Part 1

By Brittany | March 23, 2012 | Category: Pharmacotherapy
Biosimilars: Much Ado About Nothing, Part 1
By Ralph Tarantino, PhD
Pharmaceutical Consultant and Principal, SteriTech Solutions, LLC
Middletown, NJ

The eagerly awaited draft guidance on biosimilars* was finally issued by the FDA on February 9, 2012. It was drafted in the spirit of enlightened health care reform, with a view towards fiscal responsibility and. . . to annoy the nemesis of all that is good in health care, “Greedy Big Pharma.”

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