Why is affordable generic insulin not available to patients in the US? Mainly because the big manufacturers have a stronghold on the patents for this complicated "biologic" drug. But now it seems Big Pharma itself may be presenting a nice alternative.
What I'm talking about is Pfizer's new attempt to enter the injectable insulin market (less risky than their Exubera flop!) Pfizer and Biocon, a biopharmaceutical company in India, recently announced a multimillion dollar partnership that will have Pfizer marketing something called "biosimilar" insulins, which in the US are designated as so-called "follow-on" drugs by the FDA (aka a new brand in an existing therapeutic class).
In essence, it is generic insulin, but is distinctly different because of the unique nature of insulin. Unlike something like aspirin, which is a formula of chemicals that can be made by anyone in the same way, insulin can be so highly influenced in production that Regulators will only it to be labeled "similar" — not identical. Hence, biosimilar insulins.
As you may know if you follow Scott Strumello, a regular commentator on all things "diabusiness," biosimilar insulin is big news for PWDs. Right now, the only insulins for which the patents have expired are the old Regular insulins — which are pretty much outdated because of efficacy. Not that people don't or wouldn't use them, but because fewer physicians will prescribe them; why spend $100 on the old stuff when you can get something even better that's covered by insurance? On current analogue insulins (Humalog, Novolog and the like), patents won't expire until 2013 and 2015.
However, because biosimilar insulins are actually follow-ons, they can't be "interchanged" with other insulins, so they won't technically replace Humalog and Novolog when those go off-patent, but do have the potential to work the essentially the same for patients.
Still, Scott and others are concerned. He writes: "Simply stated, follow-ons should never be considered interchangable with the so-called innovator molecule. I would also like to see with follow-on biopharmaceuticals that the FDA defaults to 'non-interchangable' unless specifically approved by the physician and designated as such on the written prescription." Right now, pharmacists are allowed replace your prescription with a generic drug if it's available, but this automated step will have to be eliminated when biosimilar insulins come to market.
So where does all this leave us?
When insulin patents do expire, you can expect a big shake-up in the industry. Biosimilar insulins do seem to have the most potential for breaking the stronghold of the Big 3 manufacturers on the diabetes community as far as access and diversity of insulin. When generics or additional competition is entered into a marketplace, price usually drops. According to the FDA, a second generic version of a drug hitting the market usually sells for about half the original's price and multiple varieties often cost 80% less (!)
"More competition from our view typically leads to more innovation," says Kelly Close, founder of the leading consultancy Close Concerns. "If different analogs could be available at a lower price that are the same quality as current analogs, that would certainly benefit patients."
Kiran Mazumdar Shaw, CEO of Biocon, says, "We believe we can offer affordable insulin therapy to patients and healthcare providers and break existing oligopolies that make insulins expensive, and in many cases unaffordable. The alarming surge in diabetes the world over calls for affordable options. Insulins will always remain the foundation therapies and biosimilar insulins will have a big role in addressing this emerging global pandemic."
As highlighted by our National Diabetes Month Help Rwanda contest with Team Type1, there's an incredible need for access to insulin outside of the US. Organizations like Life for a Child, and the big pharmaceutical companies currently supply insulin to children with diabetes internationally, but donations won't cover everything, and cheaper insulin at the same quality will do more over time to increase public health than anything else. Biosimilar insulins may not be quite the same as your garden-variety generic drug, so we'll have to stay tuned to what this ends up doing to market prices globally — but it does look promising!
Quality Qs + The Waiting Game
However, Scott cautions that we might not see these biosimilar insulins in pharmacies any time soon. Salesforces for generics are often very small, and have difficulty getting in front of physicians. This means most salespeople call on the decision-makers at pharmacies, but there's often a long, complex process for choosing generic supplies. "The leaders in the field are very experienced in bidding for this business," Scott explains.
In the meantime, the FDA has to figure out how to regulate biosimilar insulins. Since they represent an entirely new "avenue" of insulin, and since they are technically not generics the way we think of them, the FDA is trying to figure out formal definitions and guidelines, and of course, quality control remains of utmost importance.
Just this week, the FDA is holding a public meeting to gather expert insight into what constitutes "similarity." Kelly says, "Ultimately, we still don't know what the timelines will be before there is a clear, defined regulatory pathway for biosimilar insulin. It goes without saying that an emphasis on quality is paramount, since manufacturing insulin is very complicated, so anything that may sacrifice quality would make patients and physicians far more scared about biosimilar insulins."