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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.

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Reimbursement concerns and the uncertainty of how interchangeability will impact biosimilar adoption are hot-button issues in the biosimilar space, Cate Lockhart, PharmD, PhD, MS, explains in this interview.

Cate Lockhart Explores the Evolution of Biosimilar Barriers 

In a recent interview, Gary Lyman, MD, MPH, an oncologist and hematologist and public health researcher with the Hutchinson Institute for Cancer Outcomes Research, in Seattle, compares the uptake of biosimilars for cancer care and other conditions and provides insight on how uptake could be improved.

The interview was published in segments on AJMC.com, the website of 

; descriptions of these segments and links to them are below.

 and the profound effect they have on the drugs that providers employ. This also affects the use of biosimilars, he notes.

 in the oncology space is high because of the need for affordable treatment of cancer. Additionally, guidelines from the American Society for Clinical Oncology and the National Comprehensive Cancer Network strongly support the use of biosimilars in oncology.

 have greater uptake than pegfilgrastim biosimilars probably because filgrastim biosimilars have been around longer and a lot of patients were given filgrastim biosimilars as an alternative to reference pegfilgrastim (Neulasta). Additionally, some patients are treated with less than the FDA-recommended dosing of filgrastim to save money, a strategy that has not been supported by clinical evidence. Lyman believes cost advantages and reimbursement, which may not be available for pegfilgrastim biosimilars, are big reasons why filgrastim biosimilars have seen such wide adoption in oncology.

 in advocating for biosimilars, he says, advising that payers, providers, and health systems reach out to patients to indicate their perspectives on these agents. He also suggests there be a better alignment between what is encouraged by the clinical community and what payers are willing to cover.

—the granting of the right to pharmacists to substitute biosimilars without consulting the physician—and the pushback on this issue. There is hesitancy to accept interchangeability of biosimilars, and physicians should have the right to keep a patient on an originator product if it’s working for them and switching could destabilize the patient’s condition, Lyman says. However, “no biosimilar has been removed from the marketplace” for failure to perform like its originator, he notes.

 can affect whether reimbursement measures or incentives will influence biosimilar utilization. He adds that interchangeability designations hold the potential to help companies market their products and encourage wider use of their biosimilars. However, Lyman stresses that if a biosimilar receives an interchangeability designation and can be prescribed in place of a reference product at the pharmacy level, without the need for physician authorization, physicians should still be notified that a switch occurred, if for no other reason than pharmacovigilance.

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Oncology biosimilars are broadly in use for good reason: They're absolutely vital for cost reduction and access, but efforts are needed to promote uptake of these agents, says Gary Lyman, MD, MPH, in this interview.

Gary Lyman, MD, MPH, Explores the Progress With Oncology Biosimilars

In a recent interview, Ivo Abraham, PhD, a professor with the University of Arizona Health Sciences in the Department of Pharmacy Practice, discussed the current climate for granulocyte-colony stimulating factor (G-CSF) biosimilars and the impact of Neulasta’s on-body injector on the US biosimilar space. Neulasta Onpro (pegfilgrastim) is an originator product that has a 51% share of the pegfilgrastim market in the United States. Ivo also talked about how the COVID-19 pandemic is influencing pegfilgrastim biosimilar prescribing patterns.

The interview was published in segments on AJMC.com, the website of 

® and the sister site of The Center for Biosimilars®, earlier this year, and descriptions of these segments and links to them are provided below.

 for pegfilgrastim is bigger than for other G-CSF molecules (lenograstim, filgrastim, etc.) because pegfilgrastim products can be used as a prophylaxis for a wide range of cancer types, whereas other biosimilars are indicated for specific disease types. For example, he said, trastuzumab biosimilars are indicated for the treatment of breast and gastric cancers in patients who are positive for human epidermal growth factor 2.

He also talked about the changing provider preferences for using filgrastim vs pegfilgrastim, saying that many providers flock toward pegfilgrastim products because the time between doses is longer and more convenient than for filgrastim products. However, some patients must be administered filgrastim products because these are significantly cheaper than pegfilgrastim products, leading some payers to only authorize use of filgrastim.

 that he co-authored; these looked at the potential savings that could be generated by switching patients from Neulasta Onpro to pegfilgrastim biosimilars. He said that the savings achieved by using biosimilars over the very convenient on-body injector could be used to provide prophylactic treatment to more patients, and said the use of biosimilars has an added safety benefit, as the Onpro carries between a 1.9% and 6.7% risk of failure.

Additionally, Abraham mentioned the provider 

 multiple pegfilgrastim biosimilars because commercial payers will make deals with different manufacturers to prefer one product over another. He said that pharmacists and clinicians use a variety of pegfilgrastim biosimilars, but payer contracts and stipulations increase the difficulty of managing multiple versions of the same molecule.

Finally, Abraham detailed how the COVID-19 pandemic has been 

 because it created conditions where reducing costs was a major priority. The pandemic also fostered an environment where confidence in biosimilars could thrive despite the history of fearmongering about the safety and efficacy of biosimilars.

Ivo Abraham, PhD, a professor with University of Arizona Health Sciences in the Department of Pharmacy Practice, outlines the current trajectory and savings potential for granulocyte-colony stimulating factor (G-CSF) biosimilars and Neulasta Onpro (pegfilgrastim).

Ivo Abraham, PhD, Discusses G-CSF Biosimilars, Such as Neulasta Onpro

In an interview with AJMC.com, the website of 

®,  and the sister site of The Center for Biosimilars®, Sonia T. Oskouei, PharmD, BCMAS, DPLA, vice president of Biosimilars at Cardinal Health, discussed the role that pharmacists can play in promoting biosimilar uptake and the first interchangeable biosimilar.

 by leading education efforts for providers and other members of the health care team. Pharmacists are also able to monitor the pipeline of anticipated biosimilars to help providers prepare and they have the added bonus of having a comprehensive understanding of the managed care landscape, which can help pharmacists identify viable opportunities or biosimilar utilization.

She delved into the potential for interchangeable biosimilars and the meaning behind interchangeability designations. Oskouei predicted correctly that the United States would see its first interchangeable biosimilar, which was 

 in July 2021 (Semglee; insulin aspart). She said that the 

 aspect of interchangeability designations is that they are relevant primarily for biosimilars that are dispensed in retail pharmacy or specialty pharmacy settings.

Oskouei also talked about how the full implications of interchangeable biosimilars is unknown, especially for insulin products, where there is strong pricing debates and a really high demand for affordable diabetes medications for US patients. She mentioned that the designation could serve as an extra stamp of approval to alleviate potential clinical concerns among providers and patients.

In regard to how providers and pharmacists 

, Oskouei discussed how pharmacists face challenges with conducting payer coverage assessments and inventory management implications stemming from varying payer policies in addition to the clinical concerns providers face.

Oskouei mentioned therapeutic interchanges as a mechanism to give pharmacists more power over biosimilar exchanges, saying that they allow for pharmacists to authorize exchanges of therapeutic alternatives in accordance with approved policies or protocols within a formulary system without requiring an interchangeable designation or provider permission.

Sonia T. Oskouei, PharmD, BCMAS, DPLA, the vice president of Biosimilars at Cardinal Health, discussed the many ways that pharmacists and interchangeability designations can affect biosimilar utilization.

Skylar Jeremias

Cate Lockhart Explores the Evolution of Biosimilar Barriers

Gary Lyman, MD, MPH, Explores the Progress With Oncology Biosimilars

Ivo Abraham, PhD, Discusses G-CSF Biosimilars, Such as Neulasta Onpro

Sonia Oskouei, PharmD, Evaluates How Pharmacists, Interchangeability Designations Impact Biosimilar Uptake