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Evidence-Based Recommendations and Safety Considerations Surrounding Biosimilars


The role of evidence-based recommendations around biosimilars and unbranded biologics to increase patient care, plus how payers and providers evaluate biosimilars through clinical data across multiple indications.

Timothy O’Shea, PharmD, MS:Evidence-based guidelines and recommendations have been universally supportive of biosimilars. You’ve had large national organizations [such as] the Arthritis Foundation, the American Diabetes Association, and the National Comprehensive Cancer Network [NCCN] all come out in support of biosimilars as being safe and efficacious and recognize their ability to reduce overall health care costs. You have had some organizations caveat their support. For example, NCCN, although they’ve come out in favor of biosimilars, they strongly recommend against single-biosimilar mandates, requirements from payers. And that makes sense. Imagine you’re a provider or a fusion center provider group and you have typically 3 or 4 main payers and several smaller payers. And in a category where there’s 5 or so biosimilars, you can get to a place where every payer is preferring a different product. And that’s going to be that. That’s going to be a challenge for them to stock all the products. So that was their recommendation. You’ve had others [such as] the American Academy of Ophthalmology, although they’re supportive of biosimilars, they recommend against off-label use of biosimilars in the eye until more clinical studies have been conducted. So overall, it’s been supportive. [We] haven’t seen specific recommendations when it comes to unbranded biologics. But the consensus there is that these are safe and effective because they’re the same product and deemed equivalent by the FDA [US Food and Drug Administration].

Evaluation of biosimilars and their indications is something that’s been top of mind for payers recently. What we often see are biosimilars coming to market with skinny labels. Skinny label means that biosimilar is coming to market with some but not all the same indications as the originator product. And they typically do that because they can bring the biosimilars to market quicker. There’s a recent analysis of the impact of biosimilars and skinny labels in JAMA [Journal of the American Medical Association], and what they had found was that of the 21 biosimilars that were approved prior to 2022, 13 of those were approved with the skinny label. And the implications or significance of that skinny label is consensus because the standards by the FDA for biosimilar approval are so strict that generally you’d expect a biosimilar to offer similar outcomes to an average originator product, even if it doesn’t have those indications in their labeling. From a payer perspective, what we’ve seen early on is that many payers have been preferring use of biosimilars with a skinny label, even outside of its approved indications. And there was a study looking at the management of skinny-label biosimilars, and [results] found that more than half of payers early on were preferring biosimilars for all indications, and that makes sense. You would expect there to be similar outcomes because of the criteria that they’re going through for approval. From a provider perspective, generally they’re recognizing that these are safe and efficacious and highly similar. So generally, providers have been on board as well.

From a safety perspective, I don’t see anything in terms of red flags, in terms of choosing from one product to another. The FDA’s criteria for biosimilar approval is generally rigorous enough where you would expect to have similar safety outcomes. That said, there are some instances, with the Humira biosimilars, for example, where you have certain biosimilar products that are latex free, and that could be important for those with latex allergies. We’ll say that if a patient does [not respond], has a safety concern, or has a contraindication to the payer’s preferred biosimilar, there are allowances that would allow the patient access to one of the nonpreferred products. That’s exceedingly rare, but there are mechanisms in place to use nonpreferred products on the basis [of whether] there are patient-specific factors.

Transcript is AI generated and edited for clarity and readability.

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