AskNadia: Buying Generic Insulin in the U.S.

Dear Nadia,

Are there a generic insulin? If so, where can I buy it?

Jessie

Dear Jessie,

There are currently no generic insulin in the U.S. market because the patents on the branded insulins have not expired. Every time a patented insulin is improved and approved by the FDA, the patent for that insulin is extended. This can go on for decades.

Biosimilar Insulin

What is coming to market is Biosimilar Insulin. This insulin is not classified as generic insulin. Most generics medications on the market are produced with the same chemical compounds as a branded medication and sold at a deep discount. Up to 80 percent less than the branded medication.

Biosimilar Insulin offers similar benefits as the branded insulin and is unlike generic medication because their formula will not be exact to the approved insulin in the market.

What is Biosimilar Insulin

Branded and approved insulin form Aventis-Sanofi, Eli Lilly and Novo Nordisk insulin is referred to as the “reference product” by the FDA. Biosimilar Insulin is approved for the same therapy (indication) as the branded insulin.

For the FDA to approve a biosimilar insulin, it must be clinically insignificant to the “reference product”; Meaning the insulin offers the same safety and effectiveness as the branded insulin.

Biosimilar Insulin that is coming to market is not expected to be as deeply discounted as the generic medications. The insulin will be anywhere from 20 to 40 percent cheaper than the branded insulin.

Basaglar- a biosimilar version of Lantus has been approved in Europe and is pending approval in the U.S. The launch date is expected to be December 15, 2016, pending FDA approval.

Once the biosimilar insulin is available in the market, it is expected that many other companies will offer competitive insulins driving the cost of insulin down and making it more readily available to the uninsured and underinsured population.

Interchangeable Biologicals

The FDA is also approving interchangeable biologicals.

If your healthcare professional prescribes you Aventis-Sanofi, Eli Lilly or Novo Nordisk insulin, the pharmacist will now have the authority to interchange a branded insulin for a biosimilar insulin assuming it has been approved for the same therapy (indication) by the FDA.

No permission is required from the prescribing healthcare professional.

Source:

John Hopkins

FDA

Lilly

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Nadia’s feedback on your question is in no way intended to initiate or replace your healthcare professionals therapy or advice. Please check in with your medical team to discuss your diabetes management concerns.

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About Nadia:


Nadia was not only born into a family with diabetes but also married into one. She was propelled at a young age into “caretaker mode,” and with her knowledge of the scarcity of resources, support, and understanding for people with diabetes, co-founded Diabetes Interview now Diabetes Health magazine.

Nadia holds 11 nominations for her work as a diabetes advocate.
Her passion for working in the diabetes community stemmed from her personal loss. She has used her experience as a caretaker to forge a career in helping others.

 

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