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 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.

Did Premarin (tablet form) have a patent? Yes, but that expired in 2012. But here we are 9 years later, and Premarin still dominates its indication.  Why?  B/c no one can duplicate it.

This doesn't mean that biologics can't be duplicated. The ones who happen to succeed have what is called a 'biosimilar'. But proving this to the FDA will be an uphill battle all the way.

In summary duplicating a biologic (even a simple one, like Premarin) is vastly complex and most companies will not even attempt it. If BP wants a biologic, their best option is to buy it.

Any company with a clinically proven biologic in its possession is sitting on a goldmine.