Will There Ever Be a Generic Insulin

FDA approval still in the works

By Daniel TrecrociDaniel Trecroci

Have you ever gone to the store to buy a bottle of name-brand cough syrup only to find, right next to the product, a similar version with different labeling and a much cheaper price? Often, the cheaper version is sold by the store where you are making the purchase (e.g. Big Box Store Cough Syrup) and a message somewhere on the label reads, "Compare to the active ingredients in INSERT NAME BRAND HERE" So, you read the ingredients then realize that it's essentially the same product—ingredient by ingredient; dosage recommendation by dosage recommendation—only $2 per bottle less. You buy this cough syrup, bring it home, take a swig and, voila, your cough symptoms go away—just as they did when you took its name-brand counterpart.

Welcome to the wonderful world of generics.

With healthcare costs climbing higher—and no relief in sight—many people take comfort in knowing that lower-priced generic versions of drugs may be available. This, too, applies to people with diabetes. In September 2006, Walmart Corporation announced a new prescription drug program to offer a list of 291 generic drugs selling for $4 for a 30-day supply. This news, however, was mostly a boon to people with type 2 diabetes who could now take low-cost versions of blood pressure meds, ACE inhibitors, sulfonylureas and—perhaps the most popular and effective type 2 drug of them all—metformin.

What About Generic Insulin?

But what about insulin—the drug of choice for type 1s and millions of type 2s? With the availability of the long-acting insulins Lantus and Levemir, as well as the fast- acting basal insulins Humalog, NovoLog and Apidra, there have never been better options for controlling diabetes through insulin therapy. These drugs, however, have all been FDA approved within the past decade, and still have their respective patent protections.

The same can't be said for Eli Lilly's Humulin insulin line or NovoNordisk's Novolin line, which lost their respective patents in 2001 and 2002. So what's stopping some entrepreneurial wizard from developing a generic line of these insulin formulations, slapping a cheap price tag on them and becoming a millionaire? Clinical trials? Forget it! According to the Drug Price Competition and Patent Term Restoration Act of 1984—usually referred to as the Hatch-Waxman Act—generics are allowed to win FDA marketing approval by submitting "bioequivelence studies"—as opposed to clinical data, which is costlier to compile.

Insulin is a Biologic, So the Rules Are Different

One problem though! According to Karen Riley of the Food and Drug Administration, insulin is a biologic drug, and that manufacturing process is different than other drugs. Therefore, insulin is not afforded the same privileges as other generics under the Hatch-Waxman Act.

In an interview with dLife, Andrea Hofelich, a spokesperson for the Generic Pharmaceutical Association (GPhA), says the FDA has yet to put forth a guidance for the approval of generic insulin.

"That's why GPhA is working with Congress to establish a clear FDA approval pathway for generic versions of biopharmaceutical products like insulin," says Hofelich, who furnished dLife with an April 10, 2007 letter signed by several governors calling on Congress to approve legislation.

The letter states, "…Nearly a decade ago, the United States Food and Drug Administration (FDA) committed to providing guidances for approval of generic versions of two kinds of biopharmaceuticals, insulin and human growth hormone. Nearly five years ago [April 2002], the scientific staff at the FDA completed work on the insulin and human growth hormone guidances, but they have yet to be released.

The letter later states, "…11 Governors have called on the FDA to release the insulin and human growth hormone guidances so that generic versions of these important and expensive products can be produced and made available to those patients who would benefit from them. We believe Congress should require release of these guidances in order to prompt the FDA to take action."

The letter also states that consumers in Europe, Australia, India, and some South American countries are currently benefiting from access to biogenerics. Hofelich says that access to generic insulins in the United States could save consumers a lot of money.

"The savings for consumers and the health care system would be tremendous—likely in the billions of dollars. Without legislation, there will be no savings for consumers," says Hofelich, adding that people with diabetes can contact their members of Congress and urge them to support legislative efforts to establish a workable FDA approval pathway that provides timely access to safe and affordable biogenerics.

Low-Cost Insulin Already Available

Another option is to use name-brand insulins at fraction of the cost. In addition to its line of generic drugs for $4, Wal-Mart also carries the ReliOn/Novolin line of insulins. ReliOn/Novolin is manufactured for Wal-Mart by Novo Nordisk, and is available in three formulations:

  • R (Regular)
  • N (NPH)
  • 70/30 (70% NPH, 30% Regular)


All three of these formulations are sold for around $50 for a three-month supply.

Read Daniel Trecroci's bio.

Read more of Daniel Trecroci's columns.

NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.

 

Last Modified Date: June 26, 2013

All content on dLife.com is created and reviewed in compliance with our editorial policy.

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