Generic Revlimid?

To completely understand the market and regulatory environments in which Revlimid exists, I would probably have to quit my day job and devote myself to full-time study for an extended period of time. Even then, I'm probably not smart enough to fathom the deepest complexities involved. But let me now take a quick stab at what I think I know about the concept of "generic Revlimid" at this point.

0. Have I mentioned how expensive Revlimid is? It is costing the health insurance company $100+K per year to keep me tuned up with it.

1. Celgene's annual Revlimid revenue is < $2 billion. In the larger scheme of the global pharmaceutical industry this is chump change, but it looms large for Celgene, representing 50-ish% of annual revenue. For the foreseeable future, Celgene really really needs this cash to continue to roll in.

2. Celgene has a protective wall of patents around Revlimid. The earliest of these expires in 2019, but Celgene appears to believe that it has defensible patents that would prevent the production of a "legal" generic version through 2026. That qualifies comfortably as "the foreseeable future".

3. Patents aside, a manufacturer of a generic version of Revlimid (at least one that could be sold legally into the US market) would have to demonstrate "bio-equivalence" of its product with Revlimid. Part of the process of so demonstrating of course involves obtaining samples of the "real thing" for purposes of comparison.

4. A couple of the big Indian generic manufacturers are working on their own versions of lenalidomide (the chemical name of Revlimid). These companies appear to believe that Revlimid's patent wall will be breached in 2019. But they are unable to obtain the requisite samples of Revlimid, because...

5. Distribution of Revlimid is very carefully controlled by Celgene. You can't just stroll down to the corner CVS with a note from your oncologist and score 28 days worth of Revlimid for a mere $10K. You have to be known to Celgene, and convince them on a monthly basis that you continue to be worthy of receiving the magic beans; and you have to work through a specialty pharmacy that has contractual relationships both with Celgene and your health insurance company.

6. ...when the Indian generic manufacturers request samples of Revlimid from Celgene, of course their requests are ever so politely refused. Celgene's position is that it "is under no obligation to supply" potential competitors with samples of its products.

7. Of course the Indian generic manufacturers could obtain Revlimid samples on the street in 10 minutes flat for the right kind of cash. But that would do them no good, because if they were to submit approval applications to the FDA based on bio-equivalence studies in which such samples were used, Celgene would instantly sue the pants off everyone in sight, since obviously these studies could only have been based on "unlawfully obtained" samples -- i.e. samples obtained anywhere other than directly from Celgene itself.

8. So how is it that, here in the land of "free markets", Celgene can get away with controlling the distribution of this product so closely -- so closely that it can't be legally obtained otherwise than directly from the manufacturer? It does so, in fact, in order to comply with FDA regulations.

9. Revlimid, you understand, is a Very Dangerous Drug. It can't be allowed to come anywhere near "a woman who is pregnant, or who could become pregnant", because of a rather extreme risk of severe birth defects. A patient taking it is not allowed to donate blood or sperm. And so on. As such, it is required by the FDA to be covered by a Risk Evaluation and Mitigation Strategy (REMS), under authority conveyed by the FDA Amendments Act of 2007 (FDAAA). And of course the REMS for Revlimid involves very strict control by Celgene over its distribution, lest the stuff fall into the wrong hands, and cause the production of monsters.

10. The FDAAA explicitly forbids using a restricted distribution program to block or delay the development of competing generic products. But of course, in the event of war, it would have to be proven in a court of law that that is what Celgene is in fact doing in this case. And accomplishing that, inclusive of the appeals process, could take years. Maybe until 2026.