Biologics - The Ultimate Goldmine
Case in Point - Premarin® (owned by Pfizer)
Premarin is a vaginal cream biologic the FDA first approved in 1942. It is considered a fairly simple biologic according to Thomas Morrow M.D. as he states below:
“Others [biologics] would include substances that are created in other organisms but are not highly complex, such as the estrogen hormones extracted from pregnant mare urine (Premarin)”
The drug has been a huge money maker for its owner. Other manufacturers and generic drug suppliers have noticed.
One would think that after almost half a century later industry would be able to duplicate a simple biologic. No – that is not the case. In fact despite the knowing source (i.e. pregnant mare urine) not even the manufacture knows its exact chemical makeup.
Despite attempts by 2 manufacturers to duplicate the biologic, the FDA rejected generic ‘alternatives’. See below.
In fact, the site drugs.com says there is no generic version of Premarin currently available. See below.
Could a generic version become available? ‘Not likely’ according to Tori Marsh, MPH of GoodRx. She writes below
Note: There are now many forms of Premarin, not just cream.