High on the wish list for PWDs is cheaper insulin. Costing over $100 a bottle (without insurance), this life-saving liquid can drain your bank account faster than your blood sugar goes up after a bowl of cereal. With so many over-the-counter and prescription drugs going generic and finally saving patients hundreds of dollars, naturally we're wondering, "When on earth are we gonna get generic insulin?"
Sadly, probably not anytime soon.
In fact, there really won't ever be "generic insulin." At least, not the way most people think of it. The term "generic" is used to describe drugs that are essentially copycats of another drug. For instance, aspirin or ibuprofen comes in many different shapes and sizes, but it's all the same drug. They all have the same active ingredient.
Insulin, however, is special. Insulin is a biopharmaceutical, which means drugs made using biotechnology, employing complicated bioprocesses, and including things like proteins, nucleic acids (DNA and RNA), living organisms, viruses and bacteria. Fun fact: "Human" insulin was the first biopharmaceutical product approved for therapeutic use. It was made using recombinant (or replicated) DNA technology... and sold under the brand name "Humulin" by Eli Lilly starting in 1982.
Other things that are considered biopharmaceuticals include glucagon, growth hormones, and vaccines.
So how come we can't have generic insulin? Biopharmaceutical drugs are much larger and more complicated to reproduce perfectly in a laboratory. The images to the right show the comparison between the insulin molecule and the aspirin molecule, for example.
Dr. Richard Dolliner, at Health Affairs Blog, the leading journal of health policy thought and research, explains why biosimilars can't be considered generics: "Because biosimilars do not utilize the same living cell line, production process, or raw material as the innovator drug, they can never be made 'identical' to the innovator biologics. This matters because small differences in molecules can result in major differences in the drug's clinical efficacy and safety."
Or another way to think of it: it's like trying to duplicate a recipe from a restaurant. You might follow the recipe precisely, but there will be variations in the ingredients and the manufacturing process that will always make your food taste different from the restaurant's original.
This is extra important in the medical world because since biosimilars are similar, not identical, they might not be considered interchangeable. That is, your pharmacist couldn't automatically make the switch between your current insulin and the new biosimilar insulin. If that's the case when biosimilar insulins are finally FDA approved, that means they'd require their own separate marketing and sales teams to educate providers and patients. Which costs more money. A lot of money.
The FDA and Biosimilars
Unfortunately, even though biosimilars hope to be an alternative to the original drug, they will still require a heavy amount of oversight from the FDA, including monitoring of manufacturing facilities, and the manufacturing process will still be intensive.
In February, the FDA released three draft guidelines on biosimilars, mainly focusing on how companies should go about applying for approval and what requirements they can expect. A biosimilar insulin will need to be essentially the same as current insulin, with no adverse events found. The FDA draft guidelines require analytical studies to be done, with animal and human clinical trials to be done on a case-by-case basis.
On Tuesday, I attended a webinar on biosimilars held by the Chicago law firm McDonnell Boehnen Hulbert & Berghoff LLP. During the webinar, Dr. Kevin Noonen explained that there were no "clear rules" that came from the draft guidance. "The FDA has given themselves maximum flexibility," he said.
Notably absent in the FDA guidelines are the issues of interchangeability and branding, including naming and labeling. Noonen says these issues are "likely to be addressed later."
For those interested, the FDA is currently accepting public comment on the draft guidance until April 11th, and there will be a public hearing on May 11th.
On pricing: As of right now, industry experts predict prices for biosimilar insulin to run about 30-70% of the cost of the original drug, whereas typical generic drugs are around 10% of the original price. In Europe, current cost savings on biosimilar drugs approved there are only about 10%. So biosimilar insulin will be cheaper, but it won't be as cheap as other generic drugs.
The Future of Biosimilar Insulin
Unfortunately, we are bearers of some sad news: the biggest Pharma player planning to introduce biosimilar insulin has dropped out. It seems like only yesterday that we were reporting on the new partnership between Pfizer and India's Biocon to develop biosimilar insulin together. But as of this month, that partnership has come to end. Each company says there are plans to continue work on biosimilar insulins, just not together, which undoubtedly indicates delays.
In a recent interview, Pfizer's Chief Medical Director, Kiran Mazumdar-Shaw said, "Pfizer is dedicated to developing a portfolio of biosimilars including monoclonal antibodies and recombinant proteins. Biocon is committed to deliver a biosimilar insulin portfolio to diabetic patients. It's in the best interest of both the companies to pursue their individual priorities."
So who will bring biosimilar insulin to market first in the U.S.?
Scott Strumello, the DOC's resident dia-business expert and someone who has followed this issue closely, says other possible major players could be the Sandoz unit of Novartis, Elona Biotech (founded by two former Lilly execs) and Teva, a pharmaceutical company currently investing in research for a compound called DiaPep277. Indiana-based Elona Biotech made the ambitious announcement in 2010 that it is developing its own manufacturing plant for biosimilar insulin. Meanwhile its neighbor, insulin giant Eli Lilly, doesn't seem terribly interested in biosimilar insulin; they make $3.6 billion on their branded insulins every year.
Because of the costs to create, approve and market this new drug, the president of Lilly's diabetes division, Enrique Conterno, told the Indiana Business Journal about the small firm Elona Biotech: "We don't believe that they're going to be highly successful." Hmmm.
Sandoz is already a major player in biosimilars, with two biosimilar products (growth hormones) already on the market. Teva has vested interested in the biosimilar market, and with its investment in DiaPep277, they are potentially another player for developing biosimilar insulin.
The breakup of Pfizer and Biocon was certainly a setback, but with more patents on current insulin products lifting within the next three years (Humalog goes off-patent next year), it's likely that more interest will develop. There are certainly hurdles in this field of research, but as many people have pointed out, with 250 million people worldwide with diabetes, there is unfortunately no shortage of need. Hopefully that need will someday cost a little less.