Biosimilars Have Saved $12.6 Billion in the US between 2014 and 2022

Biosimilars in Oncology

Biosimilars have been more widely used and implemented in oncology than in other medical fields. According to an American Health and Drug Benefits publication, the first FDA-approved biosimilar was an oncology drug called Zarxio (filgrastim-sndz).

Zarxio was first approved on March 6, 2015. Since its FDA approval, a total of 36 biosimilars have been approved. In a discussion with PharmaNewsIntelligence, Steven Lucio emphasizes the effects and implementation of biosimilars in oncology.

“Oncology has pretty much accepted biosimilars, and there are various reasons why that is the case. But they've accepted biosimilars, and the industry has seen an uptake. There are situations where the biosimilar, one or the biosimilars in aggregate, are now the market share leaders. That has not necessarily been the case with some of these other practice areas,” remarked Lucio.

Lucio discussed that the benefits of using biosimilars in oncology often outweigh the potential drawbacks.

“In oncology, there's a greater threshold for off-label use or willingness to try items to help people. There’s also a greater threshold of changing things because disease progression can change without much understanding. It seems like that community has been more willing to embrace some of the uncertainty that was initially present with the biosimilars.”

In addition, increased biosimilar usage and uptake in oncology may be associated with the period they are used in these diseases as opposed to chronic diseases.

“Most oncology agents are given for a limited time. People might come back and get them again, but it is not a drug that a patient is on indefinitely. With all things considered, that is why these other markets — inflammatory disease markets — have been a little more reluctant from a prescriber's standpoint. That’s going to be a big challenge,” stated Lucio.

Biosimilars in Chronic Disease

Lucio told PharmaNewsIntelligence that many providers managing patients with chronic diseases might be hesitant to implement biosimilars in cases where the patient is stable.

“If the patient is good, physicians do not want to change their status. There is hesitancy, given how hard it is to keep people at a certain level. The patients might be sick, but they probably are not quite under the same challenge as somebody who has an oncological condition; there just has not been as much of a threshold to accept biosimilar adoption.”

Despite this, Vizient is working to bring Humira biosimilars to the market for patients with inflammatory conditions such as arthritis in the coming year.

When asked what conditions will be most impacted by biosimilar adoption, Lucio said, “because of Humira, the rheumatoid arthritis market, the inflammatory bowel diseases market, and dermatology considerations will definitely be impacted, the list of all the things for which Humira is labeled. Historically, there haven't been many products thus far for these markets, an area that has seen limited uptake.”

Biosimilars, Payers, and Stakeholders

The implementation of biosimilars involves cooperation by multiple members of the healthcare system, including payers, providers, and pharmacists, among others.

While addressing doubts about the efficacy and safety of biosimilar drugs may relieve some provider concerns, it does not address all aspects of adoption.

“Obviously, discussing concerns of safety and efficacy doesn't address the payer circumstances and what decisions payers are making, which also influence biosimilars, which will be a key component of the Humira biosimilar landscape but from the standpoint of prescriber interest and engagement,” noted Lucio when characterizing the difference between the different populations.

For many organizations and individuals advocating for biosimilars, incentivizing payers to fund biosimilar usage is a primary concern. Lucio explained multiple ways payer concerns can be addressed.

“First and foremost is that the people in the pharmacy organizations need to be very engaged with their colleagues dealing with managed care issues, negotiating their contracts for their hospital system, for their health system, etc.”

He explained, “One of the nice things about biosimilars is that they have forced that interaction more than before. Historically, the pharmacy was associated with taking care of patients and addressing those needs — not so much engaged with how we interact with the players who are paying for that patient care.”

According to Lucio, biosimilars have “forced a greater level of connectivity, so the people in their managed care organizations are having these conversations with the payers and are saying, ‘reducing these restrictions or limits, and increasing the ability to focus on a certain biosimilar or encouraged biosimilars, will help us bring down the cost,’ which is in the payer's best interest. Again, there's a lot of complexity to that.”

Biosimilar Education

In the final portion of the interview with PharmaNewsIntelligence, Lucio emphasized the importance of education in biosimilar adoption and implementation.

Lucio stated that biosimilar adoption “must start with education and communication. Again, given what was discussed about the difference between oncology and then the inflammatory disease market, across prescribers, there's a greater awareness and understanding of what biosimilars are.”

In addition to general education, when asked about how pharmacists can encourage biosimilar usage, Lucio expanded on their role in education.

“Nevertheless, there's always an opportunity for continued education. Pharmacists have to be aware of all these elements and what it takes to get a biosimilar approved. It's a shortened process, but it's still a rigorous process. People must understand that biosimilars are not exactly the same as the originator. Similarly, the originator does not stay exactly the same. All biologics fluctuate over time. So, all those key elements must be understood by the pharmacists to be able to educate their prescriber partners.”

Beyond sharing knowledge with healthcare industry members, Lucio expands on their position by saying, “pharmacists, physicians, and nurses need to be able to explain to a patient what this is and why patients would be getting it. The clinicians should make patients aware that this could have happened, that at some point they might get a biosimilar, and they also need to be able to tell the patient, ‘because this is a biosimilar, the cost will be much less.’"

Patients, providers, and payers will continue to monitor biosimilar development and adoption. As Humira biosimilars enter the market, Vizient and other organizations will continue researching and analyzing biosimilar usage's benefits and cost savings.