Biosimilar Insulin Principles for Safe Adoption

On July 29, 2021, the U.S. Food and Drug Administration (FDA) approved the first-ever interchangeable biosimilar insulin. In recent years the FDA and the Department of Health and Human Services (HHS) have promoted policies to support and advance the development of biosimilars as one potential solution to reduce the cost of expensive drugs via increased competition. This approval marked a seminal moment for government efforts to promote competition in the insulin market.

What is a Biosimilar?

A biosimilar is a biologic drug that is almost an identical copy of the original product that is manufactured by a different company. Biosimilars are FDA approved versions of original “innovator” products and can be manufactured when the original drug patent expires. 

What is an Interchangeable Biosimilar?

A biosimilar that has achieved interchangeable status from the FDA may be substituted in place of the originally prescribed drug at the pharmacy counter.

JDRF encouraged FDA to develop a clear and reasonable pathway for biosimilar and interchangeable insulins. In March 2020, insulins and certain other biologic drugs were transitioned to a different regulatory pathway by the FDA , which opened the door for this change. With the approval of the first interchangeable biologic, it is important for health insurance plans to ensure they appropriately support patients and providers as they navigate these new options.

Interchangeable biosimilars are an important tool that will increase choice for many and have the potential to lower out-of-pocket costs. While Americans are familiar with the nature of generic substitutions for brand-name drugs, the introduction of interchangeable biosimilars is a new concept. To ensure care for those with diabetes is not inappropriately disrupted, JDRF calls on health plans, employer benefit administrators, and regulators to adhere to the following principles and take related steps to support each principle.

Awareness and Education

People with type 1 diabetes (T1D) should be fully informed and provided education as to the safety, efficacy, and potential costs of biosimilar insulins. T1D is a condition that requires constant monitoring and self-management. Education and awareness of drugs and devices are critical to successfully managing one’s diabetes. Given the novelty of interchangeable biosimilar insulins, ensuring that those with T1D are fully educated on interchangeable biosimilar insulin products and their role is vital. It is equally important that providers, particularly pharmacists, be fully educated and aware of not only the safety and efficacy of these drugs but also the potential impact on out-of-pocket costs.

Benefit Plan Awareness and Education Actions

• Health plans and pharmacy benefit managers (PBMs) should ensure that pharmacies in their network have the information at the point of sale that ensures any biosimilar they substitute is clinically appropriate and at a lower cost.

Patient Choice

People with T1D should be able to choose the insulin that works best for them in coordination with their healthcare provider and should not have their prescribed insulin substituted without their informed consent. Biosimilars will increase competition and hold the potential to lower the cost of insulin for some. Those with T1D should have broad, barrier-free access to low-cost insulin options including biosimilar insulin products.

While many compare biosimilars to generic drugs, this is not the case. By their nature biosimilars are not a copy of their reference product like generic drugs. Given the potential to interruption to a person’s management of their diabetes, no one should be required to switch to a biosimilar or any other drug due to non-medical reasons as it could disrupt someone’s successful management of their diabetes.

Benefit Plan Patient Choice Actions

• Plans should provide broad choice of insulin products and should not disrupt the care of those who, with the support of their physician, are successfully managing their diabetes by requiring a change in the insulin a person with T1D is utilizing for the sole purpose of cost reduction.

Coverage of Biosimilars Equivalent to Reference Product

T1D is a unique disease that affects everyone who has it differently. The same is true for how the insulins used to treat T1D work for individuals. To ensure that everyone has access to the therapies that work best for them, it is vital that people with diabetes have access to biosimilars as well as the reference product.

Benefit Plan Equivalent Coverage Actions

• Health plans should include a broad formulary that provides coverage of both the original reference product as well as any covered biosimilar.

• Health plans should also not cover interchangeable biosimilars in a fashion that requires someone with T1D to “fail first” via a specific biosimilar before being granted access to a brand name or other biosimilar insulin.