Replies to post #344474 on Amarin Corp Plc (AMRN)

[johngnatt]

You must be dreaming here. Generics are NOT inferior to the branded drug. If they are different from the branded version, FDA is not doing its job.

[labner]

Generics (some) are inferior

Lizaa, when I was on generic Synthroid my blood test (T4) was always fluctuating. After talking with several other thyroid patients experiencing the same on generics, I switched to branded (which I pay 3x more) and my numbers have been consistent for two years. I believe the bioequivalences of a generic should be tighter than 80-120 percent. Are you getting too much or not enough? Would they run a clinical trial with such a range?

Laura

An Excerpt from Pubmed:

Abstract
There is a widespread misconception that for a generic drug to be deemed bioequivalent to a branded drug, it must contain 80%-125% of the active ingredient that is present in the branded version. More correctly, bioequivalence is studied in randomized crossover trials that compare the generic drug with the reference agent, and the relevant outcome measures are pharmacokinetic (PK) parameters such as peak drug concentration and area under the curve, which describe the rate and extent of absorption of the drug. The ratio of each PK characteristic of the generic drug to the reference drug is computed; the ideal value of this ratio is 1:1, or just 1.00 (indicating a perfect match, or perfect bioequivalence). Because this ideal is probably unattainable, the US Food and Drug Administration requires that the 90% confidence interval of the PK ratio should lie between 0.80 and 1.25. For the entire 90% confidence interval to meet this requirement, the mean PK value of the generic product should actually lie quite close to that of the reference standard. Therefore, the variation between the generic and the reference is actually small. These concepts are explained in this article with the help of simple, easy-to-understand examples.

https://pubmed.ncbi.nlm.nih.gov/26132680/

[ranjo]

Exactly DAW will solve problem but not without mass patient and prescriber education