The FDA recently released promotional guidelines for biosimilar products. Most of it is pretty predictable, but there are some clauses to take note of. Without further ado, here is a walkthrough and interpretation of questions 2-6 of the document. Since question 1 simply states that biosimilars are subject to the same standard of examination as other products, I’ve left it out. 

Ensure consistency of nomenclature when referring to biosimilar reference products (Q2)

Question two of section three states that when biosimilar promotional materials refer to a reference product using a naming format (like the reference product’s core name), “…then it is appropriate for similar presentations about this risk in promotional materials for the biosimilar to use the same nomenclature”.

So, if your promotional materials declare, “biosimilar X is a form of substance Z. If you are allergic to substance Z then do not take biosimilar X”, then it is prudent to use consistent verbiage throughout promotion. Once you have referred to X as a form of substance Z, make sure you consistently refer to substance Z as “substance Z” rather than using its brand name, its drug class, or another naming convention.

Biosimilar promotional materials should refer to their own approved studies and labeling rather than those of a reference product (Q3).

The guidance document states,

“When developing promotional materials for a biosimilar product that include information from the studies conducted to support licensure of the reference product that are reflected in both the reference product’s FDA-approved labeling and the biosimilar’s FDA-approved labeling, firms should refer to the biosimilar product’s FDA-approved labeling. FDA has recommended that a biosimilar product’s FDA-approved labeling incorporate relevant data and information from the reference product’s FDA-approved labeling, including clinical data that supported FDA’s finding of safety and effectiveness of the reference product.”

Translation: biosimilar promotional materials should only refer to reference product studies if those studies are present in the biosimilar’s approved labeling as well. When making these references, biosimilar promotional materials should refer to their own labeling rather than that of the reference product.

In a practical example, let’s say that one reference product study in particular showed a particularly high success rate. However, that same study was not included in the biosimilar’s FDA-approved labeling. In this circumstance, the biosimilar’s promotional materials cannot reference this study when making claims.

This is pretty much a no-brainer, since making claims about your product that aren’t supported by the FDA has always been a no-no.

You ARE allowed to include studies and data that were conducted to demonstrate your product’s biosimilarity to a reference product even if they aren’t included in your product’s FDA-approved labeling (Q4).

The allowance in question four is sort of a deviation from the strict adherence to FDA-approved labeling in the prior point. But, hey, if it’s straight from the FDA then it’s fair game.

Biosimilar marketers have been given permission to refer to studies that were used to establish the biosimilarity of a product with its reference product, as long as the verbiage of the marketing is truthful to the biosimilar’s FDA-approved labeling and isn’t misleading.

Do not attempt to differentiate a biosimilar from a reference product (Q5)

Question five of the document deals with comparing a biosimilar to a reference product, and states that,

“…representations or suggestions that create an impression that there are clinically meaningful differences between the reference product and its biosimilar… or that a biosimilar is safer or more effective than its reference product are likely to be false or misleading. Similarly, representations or suggestions that create an impression that a biosimilar is not highly similar to its reference product are likely to be false or misleading.”

You can’t have your cake and eat it too. If you’re taking advantage of the biosimilar drug approval process, you can’t turn around and say your biosimilar is any different than its reference product.

Interesting Guidelines on Interchangeability Promotion (Q6)

Question six opens with a pretty straightforward command about comparing the interchangeability status of biosimilars and their reference products: be accurate. Don’t say your biosimilar is interchangeable with a reference product if it hasn’t been designated interchangeable.

However, the next guideline is slightly nebulous: reference product marketers shouldn’t imply that a biosimilar is less safe or less effective if the biosimilar hasn’t been designated as interchangeable with the reference product.

From an empirical standpoint, this recommendation makes sense: if both products have no meaningful clinical difference, then one can’t be considered inferior to another.

From a marketing standpoint, however, the lack of interchangeability is a difference. Per the FDA, an interchangeable biosimilar is a biosimilar that “can be expected to produce the same clinical result as the reference product in any given patient”. For marketers of reference products, highlighting the fact that a biosimilar without this status can not necessarily be expected to produce the same outcome as their product is a relevant message.

I’m not saying that marketers should be able to claim that non-interchangeable biosimilars are dangerous. Nor am I saying it’s the right play marketing-wise. But, if a biosimilar hasn’t been studied enough to be considered interchangeable, then that is a grey area of outcome predictability that marketers should be able to communicate to consumers and HCPs if they feel like it is pertinent.

What do You Think of the Guidelines?  

What do you think of these guidelines—are they sufficient or do you plan on submitting a recommendation before the deadline on April 2nd? We’re always happy to hear others’ thoughts on topics pertaining to healthcare advertising!

If you’re interested in reading more of our life sciences content, here’s a link to our life sciences blog. Or, if you are interested in general marketing and advertising content, here is a link to the bfw Advertising blog. Happy reading!