Experts' Perspectives: Optimal Levels for Patient Knowledge on Biosimilars

The age of biosimilars was welcomed by the medical community with open arms. The promise of equivalent therapeutics at a reduced cost to payers and healthcare systems was enticing, but the real-world adoption of biosimilars has been less than optimal in the US and abroad.

On September 15, 2023, the US Food and Drug Administration issued draft guidance outlining their intent to alter the labeling requirements for proposed biosimilar and interchangeable bio similar products for submission in an application under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). According to the draft guidance, the FDA feels the inclusion of interchangeability information on prescription labeling of bio similar products was “not likely to be useful to prescribers, who can prescribe both biosimilar and interchangeable biosimilar products in place of the reference product with equal confidence that they are as safe and effective as their reference products”.

As of September 26, 2023, the FDA had approved 42 biosimilars, with the most recent approval occurring in August when the agency approved natalizumab-sztn (Tyruko). The 20-page draft update released on September 15, 2023, represents the agency’s first update since 2018 and is intended to replace this previous guidance. As part of the review process, the FDA asking for comments regarding the draft guidance to be submitted by November 17, 2023.

With an interest in learning more about real-world uptake and conversations between patients and providers regarding biosimilars, HCPLive sat down with a trio of experts with experience in prescribing biosimilars and asked to what level patients need to be educated regarding biosimilars, bioequivalence, and interchangeability. Below, readers can find perspectives from Ryan Haumschild, PharmD, MS, MBA, director of pharmacy at Emory Healthcare and Winship Cancer Institute, Bincy Abraham, MD, MS, professor of clinical medicine in the Academic Division of Gastroenterology and Hepatology at Houston Methodist – Weill Cornell, and Jamie Thale Brogan, BA, MS, CEN, a certified nurse practitioner.

^{(L to R)} Bincy Abraham, MD, MS; Jamie Thale Brogan, BA, MS, CEN,; and Ryan Haumschild, PharmD, MS, MBA

HCPLive: How informed should patients be regarding biosimilars and interchangeability?

Ryan Haumschild, PharmD: I do think it becomes a little bit complicated when you try to mention to patients, "Well, these are biosimilars, they're not generics, and with the lot numbers there can be some variability". I think sometimes patients will sit back with you with a blank stare saying, "What are you talking about?"

So, I think we try to be succinct and what is a biosimilar or bioequivalence. This means it's been affirmed by the FDA, it means the molecular structure is the same, but biosimilars are living things. So, they are not going to be exactly the same—just like the reference product, from lotto lot it is going to be different.

Then we try to consolidate in terms of, why is biosimilar being utilized? We talk a little bit about cost stewardship and say there are not too many differences in their outcomes. We have seen this through Europe and they’ve been using them for the past 10 years

So, we try to keep it really succinct, right? These have been used before, these are data-backed, and the FDA has come forward with biosimilar infrastructure to approve these products. And I think that's the best way for patients to know. They may not need to really get in the weeds. They don't need to get too far into “We flip the pyramid and analytical studies of the base”. What they want to know is it safe, effective, equivalent, and it can be offered at a lower cost, potentially, to my healthcare system or to the payer group. So, that's why it's been preferred.

I think when we approach it that way and we're proactive, we may get some questions on one-offs, and I don't mind going into the weeds with someone that has that extra education or interest, but for the most part we give just enough information for the patient to feel satisfied so they know what is going on and they can make an informed decision.

Bincy Abraham, MD, MS: It really depends on the patient. I have patients who want every single detail about everything that I'm prescribing, ordering and whatnot. For those patients, I need to give them the nitty-gritty of everything. Otherwise, they'll bombard our staff during clinic visits with 10 pages of questions that they literally bring into our visit or send into our patient portal where we have to answer all of those. So, there is my specific group of patients where I'm actually working really hard to give exact details that actually relieves their anxiety.

On the other hand, I have another group of patients, they are completely in the in the group where they feel "Okay, my physician is providing me with this medication and recommends this medication. I trust this physician, because I've known them for many years and they have taken care of my disease for all these years. So, whatever they say, it's fine". With them, I just need to say, "Oh, this is going to be the best medication for you". I'll know my reasons and I may explain certain points of why I'm choosing this one, but for the most part, they could not care less about all the nitty gritty details. For them, it is this one is going to work for them, my doctor thinks it's going to be the safest and the best medication. They're completely fine with that.

Then there's always the middle group, that bell curve, where some of them want some additional information, and some may not need as much. I try personalizing it to what they would need. It's difficult, sometimes, to also figure out exactly where in the spectrum they fit in and take into account their educational background, socioeconomic status, and all of those things as well.

What you don't want to do is spend an hour giving them a lecture of the nitty gritty details where they could just say, "Oh, you recommend that? Okay, I'll take it". On the other hand, if you don't spend as much time in there after the visit, they could be calling about 20 other questions they forgot to ask or that I did not address. So, I usually ask them if they have any specific concerns and I'll address it that way. I can answer those specific concerns and we don't I don't have to worry about going into extremes of one or the other. So, really, the answer is: I personalize it to what the patient would want.

Jamie Thale Brogan, BA, MS, CEN: I think when I talk to patients about biosimilars, and I have admittedly not had a large quantity of my many patients on biologics have a transition. I have had a few, but the question is out there and people are hearing about biosimilars. So, sometimes it comes up.

Anytime I have seen a patient who is on adalimumab or infliximab, or really starting with all biologics, just starting the conversation that biosimilars are here, we understand them, we are comfortable with the transition, we are happy for you to transition, and, if this comes up, just know that the most important thing about transitioning is staying on schedule, because that'll maintain how effective your treatment is, and avoiding the progression of disease that we've all been trying to do.

References:

1. Joszt L. US uptake of biosimilars remains suboptimal and requires intervention. AJMC. January 14, 2022. Accessed September 26, 2023. https://www.ajmc.com/view/us-uptake-of-biosimilars-remains-suboptimal-and-requires-intervention.
2. Center for Drug Evaluation and Research. Guidance for industry. U.S. Food and Drug Administration. September 15, 2023. Accessed September 26, 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-biosimilar-and-interchangeable-biosimilar-products.
3. Stewart J. What biosimilars have been approved in the United States? Drugs.com. August 31, 2023. Accessed September 26, 2023. https://www.drugs.com/medical-answers/many-biosimilars-approved-united-states-3463281/.