Molly Billstein Leber, PharmD, BCPS, FASHP: Dispelling Misconceptions About Biosimilar Approval and Use

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Molly Billstein Leber, PharmD, BCPS, FASHP: I think the biggest misunderstanding is actually the FDA approval process and how they use the totality of evidence to actually make the approval. I think that people don’t truly understand the amount of time and energy and efforts that are actually put into the analytic data to make sure that the molecules are highly similar before they’re approved by the FDA, which is why we won’t see a lot of large phase 3 clinical trials.

I also think that among providers there is some concern about and misconceptions about the safety of being able to switch back and forth between biosimilars and between a biosimilar and the originator product. I don’t think that they truly understand that they’re highly similar and you should be able to switch back without harm to the patients. I think, also, there’s been a lot of miscommunication to patients that they should only receive 1 particular product, typically the originator. So, a lot of times there’s some misconceptions or concerns from the patient regarding which drugs should be provided.

As a pharmacist, or a health-system pharmacist, I think the majority of the content at the pharmacists’ meetings have been very good and accurate. I think that most health-system pharmacists, in an effort to manage healthcare costs and manage the pharmacy budget, have been very proactive in trying to enhance the acceptance of biosimilars and make sure that we’re educating all of the pharmacy staff members, students, interns, residents, etc., about biosimilars and how they work, and what they are, and the advantages of biosimilars.

I think right now, as far as pharmacy conferences go, I think we’re moving more away from what is a biosimilar and trying to share our experiences on how we’ve gained acceptance and how we have overcome issues such as reimbursement, so that other institutions can learn and make those adoptions.

I personally have not attended a lot of the subspecialty physician conferences. I have heard through the grapevine that there have been some presentations about how biosimilars don’t work in patients. I think the big thing to think about there is look at what the dosing was. Have they actually gone back and had those conversations? They may have gone back to the initial dosing and not at the dose that the patient was titrated up to, and that’s why they’ve been seeing failures. I think the other big thing to remind people of is that these are chronic diseases, and that they do change. We don’t see 100% response rate to biologics, the originator product, so we’re not going to see that with biosimilars. So, if they’re not responding to the biosimilar, it may be disease progression and we may need to go to another class of agents.

I talk to a lot of the different physicians who are in some of these subspecialties and I think the conversation is changing. And I think as we start seeing a lot of those guidelines come out from the big societies that are now recognizing that biosimilars are safe and effective and can be considered as first-line of care, I think that’s also helping to move the needle with biosimilar acceptance.

So, I think misinformation around biosimilars will affect the acceptance of biosimilars. I think if people don’t understand how they’re approved, how similar they are, and how effective they are, then they will not be willing to use them or try them, and then we are not going to see more biosimilars enter the market. If we don’t see more biosimilars enter the market, we’ll continue to see sole-source originator products with no competition. And, as we’ve seen in the past, we have seen steady price increases with those which may limit access to patient care.

I think it’s really important for nurses to understand what a biosimilar is because oftentimes they’re the ones administering the drug to the patient. And I think it’s important that they have that deep understanding, so that they’re able to answer any of the questions that the patient has and assure them that this is the appropriate drug for the patient. And, if they need to explain why that was chosen to the patient, I think that providers really need to understand it because they also need to have that conversation with the patient and make sure that the patient understands the benefits of a biosimilar product.


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