Now that we’ve had a fun little break, we now return to your regularly scheduled prescriptions. Biologics were promised, and biologics will be served!
Now, I know the post is titled “new drugs,” but, the reality is, biologics have been around pretty much as soon as we figured out we could stick things in our bodies and we would suddenly feel better. The actual definition of a biologic is any medicinal product produced biologically rather than chemically. So, blood transfusions, ginger, insulin, organ transplants, even the notoriously odorous valerian root are all biologics. What I’m going to be talking about today, however, is new biologics: usually products targeted toward sicknesses in which the body is battling itself.
New biologics offer possible relief for people suffering from autoimmune diseases such as rheumatoid arthritis and psoriasis; anemia sufferers; even cancer patients. Such miracle drugs should be widely available, right?
Sadly, no. If you or someone you know suffers from rheumatoid arthritis, you know that these drugs make a world of difference to a rheumatoid arthritis patient. The before and after really is like night and day. The drugs are easy enough to get to, but they cost an arm, a leg, and your firstborn. There are no generics.
Why aren’t there any generics? Well, the blessing is also the curse. Because the drugs are produced through biological processes, they target the specific biological processes that cause disease. They’re also almost impossible to reproduce by other, similar methods because of the inherent uniqueness of processes. Never mind that undetectable differences in the products can be deadly.
“But patents are supposed to be enabling! How long until that runs out? I want cheaper meds!”
Well… yes, patents are enabling. But that stuff is protected for 20 years from the application date. Usually you’ve got something shinier and newer by then. But, say we’ve got a patent expiring soon, such as the Enbrel patent. That’s supposed to expire in October 2012. A generic STILL probably won’t be available because bioequivalence is almost impossible to prove for a biologic, AND the United States law is horribly new and iffy. The infamous Patient Protection and Affordable Care Act of 2010 does allow for biologic generics to be manufactured… after 12 years of exclusive use for the original manufacturers.
Keep your fingers crossed, but don’t hold your breath.