From The Editor | September 30, 2020

The Intriguing FDA News You May Have Missed

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By Anna Rose Welch, Editorial & Community Director, Advancing RNA


In recent weeks, The Biosimilars Forum announced via press release that it had submitted commentary to the FDA’s notice entitled, “Examination of Secondary Claim Disclosure and Biosimilar Disclosures in Prescription Drug Promotional Materials.” If you’re like me, you probably just went, “Say what now?” (If you are completely in-the-know, then congratulations! You are on top of things.)

Chances are though, this one was not at the top of your radar. To be fair, there’s been a lot of hot regulatory policy news to take in, including this paper out of the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) pushing for the elimination of routinely required comparative efficacy and safety trials. There was also this policy guide from the International Generic and Biosimilars Association (IGBA) — a companion piece to this groundbreaking publication on the path toward tailored clinical trials. I like to characterize these efforts as being akin to giant boulders disrupting a still pond. You can’t help but take notice.

This news out of the FDA is not necessarily a boulder, but it is still certainly worth noting as it touches upon several themes that have been top of mind this year. Here’s what you should know about the FDA’s latest notice:

Who is involved?

The Office of Prescription Drug Promotion (OPDP). The OPDP ensures that drug promotional materials accurately present facts about a medication so patients and providers aren’t led astray in their treatment decisions. OPDP often examines the format and content of drug advertisements and how specific populations may react to a drug’s communicated clinical benefit/risk profile. Long-story short, the OPDP has decided to set their research sights on biosimilars.

“Whatcha talkin’ ‘bout, Welch”?

The OPDP has proposed conducting a two-phase research project. Phase 1 is unrelated to biosimilars — Phase 2 is the one you should know about.

Phase 2 will examine how a biosimilar disclosure statement may impact patients’ and providers’ perceptions of biosimilars.

…And a biosimilar disclosure statement is?

Glad you asked! A biosimilar disclosure statement essentially lets patients and prescribers know that the medicine they are reading about or considering is a biosimilar. Sounds simple enough, right? Not necessarily.

How detailed those disclosure statements may ultimately be is still TBD. In fact, the ODPD actually has seven (yes, seven!) “different disclosure conditions” they would like to run by participants. These statements would, firstly, disclose that the product is a biosimilar. Each statement would then be followed by one, two, or three basic informational statements about the biosimilar. Samples of these additional statements include:

The biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product.”

This biosimilar is made from the same types of sources as [brand name of reference product].

[DRUG NAME] is given the same way and has the same strength and dosage as the FDA-approved original biologic.”  

If you want to take a closer look at all the different disclosure options the OPDP has pitched, the Biosimilars Forum spelled them out in its comment letter to the FDA.

The OPDP has also specified there will be a control group in which no disclosure statement and/or biosimilar facts will be provided.

Why are they interested in carrying out this research?

Outside of determining how such statements impact patient/provider willingness to use biosimilars, other purposes for carrying out this research haven’t been directly stated.

That said, this effort does tie in nicely with the FDA and FTC’s prominent partnership to tackle disparagement and “end the shenanigans,” as Scott Gottlieb would say. In fact, earlier this year, the FDA released a guidance on promotional and educational information after hearing industry concerns that biosimilars have been misrepresented in some past “educational” efforts. The FDA and FTC co-hosted a workshop together in March (pre-pandemic shutdown) to further discuss educational, anti-trust, policy, and market-based and regulatory hurdles to biosimilar competition, as well. 

What does the industry have to say about this notice?

Overall, the biggest question for the biosimilar industry moving forward will likely be why the FDA feels biosimilar disclosure statements may be necessary in promotional materials. (In fact, even calling them “disclosure statements” can sound as though something illicit is afoot.) 

Altogether, there was a small handful of comments on the notice from Bayer, AbbVie, PhRMA, The Biosimilars Forum, and the Hematology/Oncology Pharmacy Association (HOPA). Comments were mixed, with several respondents focusing primarily on Phase 1 of the research plan. AbbVie and PhRMA specifically took issue with the inclusion of an originator product’s brand-name being included in several of the draft test statements. The Forum’s comments are the most biosimilar-centric and well worth a read for all the juicy details.

What are the biggest highlights from The Forum?

One of the main questions The Forum would like clarification on is what value the FDA anticipates such disclosure statements will add — particularly to patients’ biosimilar understanding and trust. Should disclosure statements ultimately become a common addition to promotional materials, there should be some measurable data demonstrating improvement in patient confidence in biosimilars.

As such, The Forum would like to see this research focused on patients as well as on to healthcare providers (HCPs), perhaps in parallel studies. (HCPs remain critical stakeholders, but there have been more regular efforts over the past few years documenting provider’s growing knowledge of biosimilars compared to patients.) 

The Forum also emphasizes throughout the importance of using patient-friendly language and avoiding overly complex and confusing terms/phrases (i.e., interchangeability, extrapolation, & no clinically meaningful differences). Close attention to sentence structure, tone, and vocabulary will ensure such statements do not create any negative perceptions.

Give me the big picture and I’ll be on my way!

Misinformation and disparagement have been hot topics since the launch of the first biosimilar in the EU in 2006 and in the U.S. since 2015. This year alone, however, has been an arrival point of sorts for the U.S. industry and other key agencies for addressing these problematic efforts. In addition to the FDA-FTC partnership, the industry saw its first publication thoroughly documenting the most notable types of biosimilar misinformation and disparagement. This paper ultimately served as a call-to-action for all stakeholders to actively educate and counter efforts to limit biosimilar competition.

This latest effort out of the FDA — though quietly announced — is a sign that stakeholder perceptions of biosimilars are top-of-mind for the agency and that certain projects are being put in place to examine how certain forms of information may impact patient-provider acceptance.