Replies to post #237512 on Amarin Corp Plc (AMRN)

[Pharmacydude]

Montana

See: https://www.fda.gov/drugs/generic-drugs/what-approval-process-generic-drugs

[Pharmacydude]

More about determining if a generic truly is equivalent.

“It’s true that the PK values are required to fall between 80% and 125% of the reference value in these randomized, crossover trials. More importantly, however, the entire 90% confidence interval (CI) of the observed PK value must also fall between 80% and 125%.”

See: https://www.pharmacytimes.com/contributor/timothy-o-shea/2016/06/debunking-a-common-pharmacy-myth-the-80-125-bioequivalence-rule

In my opinion as a pharmacist, generics are generally equivalent to the brand drugs for standard pill formulations. Where I become concerned is when the drug has a specialized delivery system (eg long acting, delayed release etc). Vascepa’s unique processing and encapsulation to prevent oxidation is where I wouldn’t trust a generic.

Example: Concerta
The brand and generic have completely different delivery systems and the duration of action is not IMO the same. I had the same feedback from many Pts’ parents and had the same experience with my children. It was very obvious the difference yet was an approved generic. My kids use the brand name Concerta now.

[sts66]

Generics have to create the drug and test it for bioequivalence, usually things like time to peak serum levels and half life of metabolites - basically has to work identically to the brand name drug within some +/- % range. What I'd like to know is how you prove a GV has the same shelf life as V - 4 yrs due to our patented encapsulation process - and as previously mentioned, how do they get around that patent to start with? I used to do enhanced life testing on products where every +10C was equivalent to 1 yr of operation at room temp - you could get 4 yr results in 1 yr by running 40C hotter than nominal temps - if there's an equivalent type of sped up shelf life testing for drugs I'd like to see how you do it. The accelerated life testing I'm talking about is used to monitor chemical reactions between different materials, in my case usually a liquid inside a metal container - I think electronics are tested in a similar manner, run them hot and watch for failures. For GV you'd look for interactions between the atmosphere and the capsule contents, measure oxidation rates, but I'm not sure the same equations and techniques work for drugs, meaning simply testing at elevated temps would yield the results you're looking for - the capsule material might be fine at room temp + 30C but break down at room temp + 40C.