Cate Lockhart Explores the Evolution of Biosimilar Barriers

In an interview with The Center for Biosimilars®, Cate Lockhart, PharmD, PhD, MS, executive director of the Biologics and Biosimilars Collective Intelligence Consortium, discusses some of the current barriers to biosimilar adoption in the United States and how the industry is working on overcoming them.

Lockhart explains that the status of biosimilar adoption has changed. There was uncertainty and lack of knowledge about the science when biosimilars were first emerging. Now, the uncertainty has been shifted to concerns regarding reimbursement and management, especially as more biosimilars are approved.

As market competition increases, Lockhart says, reimbursement capabilities and formulary designs become more important, because product stocking in a health system or hospital pharmacy is complicated. Providers may be forced to stock all biosimilars approved for a particular reference product and reimbursement may not apply equally for them.

She mentions that some practitioners have concerns over how benefit design and formulary practices will impact their daily workflow. Lockhart says incentives for payers to use certain products may support the use of biosimilars, especially now that there are multiple alternatives to some reference drugs.

Previously, most biosimilars were under the medical benefit; however, some pharmacy benefit biosimilars have started to emerge, and Lockhart is interested in seeing how these biosimilars will change the landscape. Lockhart expects pharmacy benefit biosimilars to play a more prominent role in the decisions that formulary managers make.

Emerging insulin biosimilars will be some of the first products to go through the pharmacy benefit, and Semglee (insulin glargine) was recently approved as a biosimilar with an interchangeability label. Lockhart explains that interchangeability designations for insulin products add complexity. Although she says it’s too soon to tell whether interchangeability will have a significant impact on adoption of insulin biosimilars, she believes more biosimilar manufacturers will seek interchangeability designations.

Finally, Lockhart dives into the subject of how biosimilars can be leveraged in use management programs, saying health systems should refine their coding and administrative systems to help ensure that programs run as smoothly as possible and that workflow is not disrupted.