ASHP Midyear: Real-World Data Collection Helps to Facilitate Successful Biosimilar Adoption

The evolving regulatory policies around biosimilar interchangeability is crucial for driving successful biosimilar adoption in the marketplace.

Amanuel Kehasse, PharmD, PhD, director of clinical programs and drug information at Clearway Health, highlights the importance of real-world data collection in understanding the long-term safety, efficacy, and patient experiences with biosimilar medications. While clinical trials provide valuable data for regulatory approvals, they are limited by controlled environments and lack of diverse patient populations. Kehasse emphasizes that medication efficacy is heavily influenced by environmental and social factors, making real-world data essential for evaluating long-term outcomes and comparative performance between reference products and biosimilars. Collecting this data can provide insights into patient adherence, therapy persistence, and the factors driving successful biosimilar adoption in the marketplace.

Pharmacy Times: What is the role of real-world data of biosimilars to identify potential safety signals or efficacy concerns?

Amanuel Kehasse: That's actually really key because we know clinical trials generates really good data, right? That's what's leading to FDA approvals, but clinical trials are controlled environment in a way. You don't have the diverse patient population [and] the environmental impact of the medication efficacy. We know medication efficacy is 20% clinical, 80% environmental impact, right? It includes like social determinants of health in multiple factors. So once you have this approved, collecting the real world data is really important. It will allow us to, for example, see the long term safety and efficacy of these medications because clinical trials will have a limited time of study. So will allow us to see the long term effect of this medication in terms of their safety, efficacy and immunogenicity. It also will allow us to have a comparative data like inevitably, some patients will be on the reference products. Some will be in biosimilar number 1, another biosimilar number 2. So when you collect all this data and compare, it will give you an insight, how is the patient experience with reference versus biosimilar number 1, biosimilar number 2, in terms of adherence to medication, persistence with therapy? Are patients on one biosimilar continuously beinginterrupted in their therapies? What is causing that? It will allow us to understand a lot of the the processes and the factors that will either make biosimilar adoption successful or not in the marketplace.

Pharmacy Times: There are a lot of misconceptions about interchangeability. What does interchangeability status mean, and what are the criteria for determining interchangeability?

Amanuel Kehasse: That's a concept that is constantly changing, and it is one of the key things actually we think will be a driver for a larger biosimilar adoption, not that we have subcutaneously administered biosimilars that are dispensed it at the pharmacies, not clinically administered ones. So to begin with, the designation of interchangeability is not a clinical designation. It is only a regulatory designation. It doesn't mean the clinical efficacy safety of this biosimilar that has interchangeability designation is better than the others to begin with. An interchangeable biosimilar has to be approved as a biosimilar first, and the manufacturer can ask for intestability designation. So that means the pharmacist at the time of displacing can make a switch to the biosimilar for the reference product prescription at the time of dispenser without the need to generate new prescription from the physician. We've seen this one all the time in generic medications when a brand medication is ordered, unless the physician puts a note dispensed as written, which means brand only dispensing, the pharmacist automatically changes this one to generic medication, so interchangeability will be exactly the same concept. The pharmacist will be able to change this one to biosimilar if that designation is given to that drug. The other thing is, like, I want to hammer this one down, a molecule that has interchangeability designation does not mean it is clinically superior to those that doesn't have that designation. It's a simple regulatory designation, but one key information that I want to also highlight is this probably will change. So previously, to gain an interchangeability, you have to do multiple clinical trials, that is switch between reference product to the biosimilar back and forth and make sure that there is no significant clinical outcome when you're switching between both. Now FDA is actually considering to eliminate those kind of requirements because it's one of the burdens that the biosimilar have before they come to the market.

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