Inhaled Insulin, Biosimilars Will Change the Landscape of Diabetes Care

Insulin glargine injections (Basaglar) and inhaled insulin (Afrezza) are two new diabetes treatment options worth exploring. The introduction of these drugs will create competition over drug pricing, just as the patent on insulin glargine (Lantus), made by Sanofi, is set to expire in 2015. 

Lilly and Boehringer Ingelheim will manufacture Basaglar, a new long-acting insulin injection. Basaglar received tentative approval from the Food and Drug Administration (FDA) for adults with type 2 diabetes, and for both children and adults with type I diabetes. This basal insulin provides a long lasting, “base” level of insulin. This way, the patient’s body is ready to process the glucose they eat, instead of requiring the patient to inject a fast-acting insulin right before a meal.

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Scientists call upcoming new versions of bio-engineered drugs like insulin “biosimilars,” because even though the finished product must be very close to the original and produce very similar therapeutic results, they are made by different companies with different processes. Basaglar is one such biosimilar. It is chemically very close to Lantus, but it will likely be priced lower because biosimilars, like other kinds of generic drugs, are typically less expensive than their branded counterparts.

Inserting Genes into Bacteria

Human insulin products are made by inserting human insulin genes into a bacteria (in this case, E.coli). The bacteria then multiply to make the insulin. Many processes are required to make the product, including purifying and packaging, and each manufacturer uses its own proprietary methods.

Alan Carter, Pharm.D., from medical research organization MRIGlobal, told Healthline, “When you make these protein compounds (like insulin), there are other protein fragments present from the manufacturing process.”

In an article in January 2014, which appeared in the Journal of Diabetes Science and Technology, Carter said that these impurities may originate with the host (the bacteria used to make the product), the manufacturing process, or the product itself (the packaging or inhaler system). 

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Caution Urged When Switching Drugs

Carter’s concern is that although healthcare providers and drug manufacturers already know about these minor variations in biosimilar products, if patients are switched from product to product, they may have variations in blood sugar, or potentially develop antibodies or resistance to insulin.

Some patients do develop resistance and require increasing doses of insulin to keep their glucose levels under control. Generally, when patients stay with one product, they have more consistent results.

Patients are often excited to see new treatment options, but providers, who may work with a patient for years to achieve good blood glucose control, hesitate to switch well-managed patients to new products.

The decision by patients or their physicians to switch brands of insulin are often prompted by insurance companies, not doctors. As more manufacturers enter the insulin glargine market, prices will fluctuate and insurance companies may ask patients to use newer, less expensive types of insulin.

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Inhaled Insulin in a Dissolving Powder 

Afrezza is another new alternative to treat diabetes. Approved in June by the FDA, this new rapid-acting insulin is inhaled instead of injected. Afrezza will be manufactured and sold through a joint agreement between MannKind Corporation and Sanofi. 

Afrezza is not the first inhaled insulin. Pfizer released Exubera, which was highly anticipated, but the product was withdrawn within two years due to poor sales (it had a large, cumbersome inhaler). Other competitors also discontinued development of inhaled insulin at the same time.

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Afrezza uses the pocket-sized Dreamboat inhaler. According to product information, the insulin is powdered and encased in a matrix of FDKP, a material that dissolves almost instantly, releasing the insulin, when its inhaled. This new delivery system helps insulin enter the bloodstream nearly as fast as an injection.

Patients with obstructive lung disease should not use Afrezza, and acute bronchospasm is a potential side effect of the drug. Patients with cancer are also warned not to take the drug. Tests have also shown that Afrezza does not lower HgA1C levels (a measurement of long-term blood glucose control) quite as well as injected insulin.