New Insulin Versions on the Horizon

The availability of new insulin versions in the near future will provide choice and value to providers and patients, according to a new study.

“New insulin versions will have the potential to expand market competition and increase insulin's accessibility worldwide,” stated the authors, led by Anne L. Peters, MD of the University of Southern California.

Patent protections for several insulin preparations have or will expire in the near future, allowing the entry of new insulin versions into the marketplace.

The first biological manufactured using recombinant DNA technology to be approved by the FDA was Humulin® insulin in 1982. Other human insulin products to follow included regular insulin, neutral protamine Hagedorn insulin, rapid-acting analogues, basal analogues, and premixed insulins.

Several companies around the world have begun to manufacture and market similar insulin products under local standards that may differ from the standards that exist in more established regions, the researchers noted.

Devices used to administer insulin will “add an extra layer of complexity to the introduction and approval of biosimilars and new insulin versions,” they stated. The use of pen devices in the US has increased since 2004, while use of the traditional vials or syringes has steadily decreased.

Delivery devices can affect dosing accuracy, convenience, comfort, adherence, and treatment persistence, and prefilled and reusable pen devices must also satisfy regulatory requirements. Cartridges, pens, and pumps must be approved with each insulin formulation and concentration to be used.

“The FDA states that new insulin versions can use a delivery device or container closure system that is different from the reference listed drug, but the route of administration must be the same,” they stated.

“For patients using prefilled or reusable insulin delivery devices, the delivery method must be reliable and compatible with the new insulin version it is designed to contain.”

The authors noted that biopharmaceuticals may evoke immune responses. Many patients safely receive recombinant human insulin and develop anti-insulin antibodies, but severe reactions have been documented. Biopharmaceutical-induced immunogenic responses can lead to reduced efficacy and systemic immune responses. Possible immune responses include allergy, serum sickness, anaphylaxis, and severe or fatal reactions, such as the pure red cell aplasia encountered with a particular formulation of epoetin alfa.

“When new insulin versions arrive, the plethora of choices may cause confusion and uncertainty among patients and healthcare providers. The complexity of these biopharmaceuticals and their manufacturing processes may lead to prescriber concern about comparative product safety and efficacy. These concerns may initially slow the adoption and use of new insulin versions by patients and providers,” they stated.

The use of similar biologic products will improve along with lower costs and a better appreciation of the regulatory approval process by prescribers, they suggested. Delivery devices may also impact prescriber and patient choice. New prefilled and reusable insulin delivery devices will require education and training for patients, significant others, and caregivers.

Also, the clinical data package, the approved delivery device, and the end user cost will influence prescribers' confidence and utilization of new insulin versions, they stated.

Reference: Peters AL, et al. Biosimilars and new insulin versions. Endocr Pract. 2015 Dec;21(12):1387-1394.