FDA Biosimilar Naming Guidance Reveals Larger Healthcare Needs
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
We’re just a few weeks into 2017, but so far, the FDA has been on a roll. In late December (basically 2017), the agency released its finalized guidance on Clinical Pharmacology Data To Support A Demonstration Of Biosimilarity To A Reference Product. And, just this week, the FDA released its highly anticipated interchangeability guidance, which I’m sure will lead to many conversations and debates at conferences and in my future articles. And last, but certainly not least, the FDA also published its final guidance on biologics and biosimilar naming.
There were no major surprises within the naming guidance. My biggest unanswered questions following review of the draft guidance were whether the FDA would keep its proposal for meaningless suffixes, and if these suffixes would also be assigned to reference products. Overall, the agency remained steadfast on those decisions. (Important to note: the protocol for interchangeable biosimilars/biologics suffixes has yet to be determined.)
We’ve seen press releases from The Biosimilars Forum and the Biologics Prescribers Collaborative (BPC) praising the FDA for completing the guidance. But these organizations continued to voice concerns about the use of “random” suffixes instead of meaningful ones (i.e., the original, though soon-to-be-changed suffix, given to Sandoz’s Zarxio, filgrastim-sndz). These concerns haven’t changed since the release of the draft guidance in August 2015. It’s questionable if suffixes will make the biosimilar, which is supposed to boast “fingerprint-like similarity,” appear too different from its reference biologic. And many are still concerned suffixes will be confusing to physicians and pharmacists.
To be fair, we do not necessarily know what to expect in terms of the suffix learning-curve among physicians and pharmacists. Since we only have two biosimilars on the U.S. market right now, both of which are for different reference products, the naming system will likely be less confusing as we start out. As additional biosimilar competition is added amongst each reference product, we will see how stakeholders fare.
However, like many others, I am primarily focused on the impact this guidance will have on biosimilar tracking. Those of you who have been reading my articles regularly will know I’ve been on a real-world evidence (RWE) kick. I’ve spent the past few weeks delving into conference presentations about the challenges of determining how biosimilars will fare years down the road. One of these articles, based off a presentation by an Amgen epidemiologist, homed in on the difficulties of tracking biologics using claims data.
Indeed, the FDA naming guidance itself admits that current biologic drug identifiers (i.e., national drug code [NDC] number, lot number, and billing codes) have proven unreliable for identifying drugs and tracking adverse events. For instance, as the guidance describes, “Product identifiers, such as NDC numbers, are not routinely recorded in billing and patient records in many clinical settings in which biological products are dispensed and administered, and therefore the utility of these alternative identifiers in active pharmacovigilance is limited.”
As such, the four-letter suffix, which will be part of the international non-proprietary name (INN), is supposed to help identify a product when the J-codes and NDC codes don’t differentiate products or are not included in claims forms.
In a recent article, I noted that Amgen found 50 percent of claims forms for G-CSF drugs (filgrastim and pegfilgrastim) did not include an NDC. Similarly, as all biosimilars for the same reference product are expected to share the same J-code, that specific number will not reveal which company made the biosimilar — especially when the NDC is not included.
However, never fear. At the DIA conference during a Q&A session, one FDA official said the Centers for Medicare and Medicaid Services (CMS) has indicated there will be a two-digit modifier added to the end of each J-code to indicate the specific manufacturer. This modifier will be required on claims forms. But this doesn’t necessarily make me feel any better.
Between the four-digit J-code and its two-digit variable, the 10-digit NDC, and now the four letter suffix, there are altogether 20 different numbers and letters available for identifying a biosimilar. This doesn’t include lot numbers or the proprietary name of a biosimilar. It's also important to call attention to the FDA's Standardized Numerical Identifier (SNI) for prescription drug packaging, which the FDA is in the midst of implementing to ensure supply chain security.
If NDCs and the other already-existing methods of identification are not currently being used, it seems adding more identification methods into the mix will just be another losing battle to differentiate.
In the end, it seems the biosimilar industry needs fewer solutions for identifying biosimilars and more work on the healthcare end to improve overall reporting.
As Amgen’s Brian Bradbury argued in the Q&A for his panel at DIA Biosimilars 2016, complete adoption and use of NDCs in all settings of care will be necessary. Otherwise, we will continue to fight a losing battle to identify medicines. Quintiles’ Nancy Dreyer also pointed out the need to educate staff and nurses in hospitals and doctors’ offices about how to document these codes in full and understand the necessity of including them.
Whether the suffix will replace the need for more vigilant reporting of NDCs has yet to be seen. I intend to wait patiently and find out. But it seems training and ensuring compliance in healthcare settings is the next big step to make sure at least one of these many identification tools is reliable in the future.