Biosimilar Insulin Will Be Available Soon: What It Is and Why It May Help

If you haven’t already, it’s time to add the word “biosimilar” to your diabetes vocabulary.

The FDA has approved a December 2016 launch for the biosimilar insulin glargine, trade name Basaglar.

In the world of pharmaceuticals, biosimilar drugs are a bit like designer knock-offs. They are copies of a biological molecule earlier approved for medical use. The biosimilar Basaglar, for instance, is a copy of the previously approved insulin glargine, popularly known as Lantus.

Almost Identical

The patent protecting Sanofi’s Lantus expired last year, leaving other companies free to make their own versions, such as Basaglar, which offers a similar glucose reducing effect for people with type 1 or type 2 diabetes.

However, the making of biosimilars such as Basaglar is a highly sensitive process involving unpredictable living organisms, so the copies are never identical to the original. They carry the same primary amino acid sequence, but differ in more subtle molecular attributes.

Production variations also affect biosimilar products. An original drug’s patent holder does not have to divulge the protocols, techniques, and reagents used in their manufacturing process. Biosimilar makers must substitute their own systems and materials to produce a copy of the prototype.

Cost Cutting

Since they are not exact facsimiles, biosimilars cannot be automatically substituted for the original medication by a pharmacist, but they should - as generics do - reduce our drug costs.

Biosimilar price reductions are predicted to be modest owing to the expense of developing, manufacturing, and marketing them. Savings of 15 to 20 percent are expected for Basaglar, reflecting the cost reductions reported by countries where this biosimilar was already launched. Generic drugs, in comparison, save consumers 50 to 80 percent over the patented originals.

Still Some Questions

Though the medical community has been eagerly anticipating the release of biosimilars they are not without controversy. It’s unknown whether they will actually improve patient care, or how well they will fare in the marketplace.

When surveyed, diabetes doctors and educators reassuringly expressed the desire for strong evidence that a biosimilar is “equivalent” to its original in every respect. This includes storage, stability, its expiration once in use, and reliability of results.

Insurance companies have also conveyed concern about the safety and effectiveness of biosimilars, wanting clinical confirmation of their interchangeability with the original product—before reimbursing users. However, the FDA stamp of approval on biosimilars such as Basaglar may ease payors' skepticism.

More Coming

Basaglar is a Lilly/BI product, and other companies are creating insulin glargine biosimilars as well. A biosimilar of the rapid-acting insulin Humalog is also in the works. As more patents expire, we consumers will likely notice a surge in biosimilar pharmaceutical options.

Sources: Medscape; Diabetes In Control; Diatribe; Clinical Diabetes Journal
Photo credit: Jill Brown

More Articles

Diabetic shoes are important as a common side effect of diabetes is "peripheral neuropathy," which causes loss of sensation in the extremities....

There’s something inherently playful about bouncing, which is why so many people enjoy rebounding. Rebounding, or exercising on a mini-trampoline...

Do not let pictures of yoga experts with their bodies twisted into bizarre, compact shapes fool you. Even people with stiff muscles, creaky joints...

One of the hardest parts about adopting a low-carb diet is giving up traditional baked goods and sweets. The good news, however, is that low-carb...

Insulin injections are a way of life for many people with type 1 or type 2 diabetes, but for some people, they can be a little intimidating at...

More Articles

You may think beer, wine, and liquor would be categorized as food, but in reality, alcohol is a drug. Just like medications, alcohol has powerful...

One of the hardest parts about adopting a low-carb diet is giving up traditional baked goods and sweets. The good news, however, is that low-carb...

With such a marked increase in the number of new diabetes cases, more people are wondering if type 1 diabetes...

Experts estimate that somewhere in the world a person with diabetes will lose a lower extremity every half minute due to a wound. One of the...

Anyone can develop a fungal skin infection, but people with diabetes are more prone to them. A common cause of fungal infections in those with...

Many diabetics struggle to control the sudden blood sugar spikes that can occur after meals. Knowing why blood sugar spikes happen and making...

Do not let pictures of yoga experts with their bodies twisted into bizarre, compact shapes fool you. Even people with stiff muscles, creaky joints...

With diabetes, it all used to be really simple: Type 1 diabetes was known as “childhood-onset,” and type 2 was “adult-onset” diabetes. The cause...

People often get diabetes and hypoglycemia confused with one another, believing that they are two different names for the same condition. In...

Diabetes is a health condition that disrupts the body’s normal production of insulin. Currently, more than one million Americans are diagnosed...

Insulin injections are a way of life for many people with type 1 or type 2 diabetes, but for some people, they can be a little intimidating at...

There’s something inherently playful about bouncing, which is why so many people enjoy rebounding. Rebounding, or exercising on a mini-trampoline...

Diabetic shoes are important as a common side effect of diabetes is "peripheral neuropathy," which causes loss of sensation in the extremities....

The medical community relies heavily on the goodwill of its citizens, as giving blood and organ donations help save thousands of lives every year...

There are several misconceptions about Diabetes. Learn more about the top misconceptions vs. facts surrounding Type 2 Diabetes below.

86...