Biosimilars Could Provide Huge Savings in Future, But Patient Education is Needed


Clinicians raise concerns about immunogenicity, product quality, and reimbursement for biosimilars.

Increasing the use of biosimilars could result in larger cost savings for the treatment of multiple disease spaces, according to a review published in Clinical Pharmacology & Therapeutics. Although there are significant barriers to overcome that are inhibiting clinical adoption of biosimilars, education could promote biosimilar adoption, according to the study.

Image credit: Carl |

Image credit: Carl |

A biosimilar is a product that is formulated differently than an innovator biologic, the reference product (RP), but has no clinically meaningful differences from the RP. The biosimilar must also satisfy safety standards and it can only enter the market once the innovator biologic loses market exclusivity. Biosimilars can be exponentially more affordable as well.

“Sales of biosimilars, priced 11%–45% lower than their innovator counterparts, have the potential to achieve considerable savings for payers,” the study authors wrote. “Between 2020 and 2024, biosimilar sales are expected to result in $109 billion in savings, as newly approved biosimilars launch and existing biosimilars see continued uptake and price reductions.”

Prescribers must be confident that biosimilars are safe and effective before using them in clinical practice, but one of the main barriers associated with biosimilar adoption is price, notably with oncology biosimilars. A 2018 study found that oncology biosimilars accounted for 6 of the 10 most expensive biologics covered under Medicare Part B.

In addition, manufactures of an innovator biologic may start a “patent dance” with a biosimilar manufacturer. During this time, the innovator manufacturer will file secondary patents to extend their period of product exclusivity.

“Resolution can be obtained through settlement or litigation, resulting in either a delay or no delay in the launch of the biosimilar,” the researchers wrote.

Oncologists are reportedly wary of biosimilars for an indication that is not under clinical evaluation, according to the study. They also remain wary that the development of biosimilars does not rely heavily on clinical data to determine efficacy or safety. In addition, clinicians have raised concerns about the immunogenicity associated with biosimilars; reimbursement following biosimilar adoption; substitutions; indirect versus direct patient cost saving; manufacturing changes that may impact quality; and possible unfavorable therapeutic effects after switching from an innovator biologic to biosimilar, according to the study.

There are specific concerns about insulin biosimilars as well. With 4 categories of insulin products approved right now (rapid-acting, short-acting, intermediate-acting, and long-acting insulins), new biosimilars must have a wide range of pharmacodynamic profiles. In addition, patients may be concerned about differences in the device that administers the biosimilar product and increase the approval of insulin products that have an interchangeability designation.

Educating providers and patients is necessary to drive biosimilar adoption. In a 2018 survey asking managed care and specialty pharmacy professionals about overcoming barriers to biosimilar adoption, 91% of respondents reported that prescriber education would improve biosimilar adoption; and 90% said that adoption would improve if the FDA provided education about the pharmacy-level substitutions of biosimilars for RPs.

When providers can educate patients, use of biosimilars is likely to rise, the study noted. This may include educating patients with diabetes about how to use the device and suggesting the use of FDA-regulated products over low cost or poor-quality products. Providers should educate patients about biosimilars prior to beginning use of it, according to the study.

“Educational efforts now need to be undertaken at the grass-roots level and target patients and advanced practice providers…few of whom prescribe biosimilars,” the study authors said. “These efforts should aim to educate patients and care providers, with an emphasis on the high regulatory standards that biosimilars need to meet for approval, as well as the benefits of biosimilars to health care systems.”


Shubow S, Sun Q, Nguyen Phan AL, et al. Prescriber Perspectives on Biosimilar Adoption and Potential Role of Clinical Pharmacology: A Workshop Summary. Clin Pharmacol Ther, 113: 37-49. DOI:10.1002/cpt.2765.

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