From The Editor | August 24, 2015

Could AbbVie Hurt Itself With Biosimilar Labeling Demands?

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

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In May, the FDA changed its stance on several key points of its draft version of the “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product.” In accordance with these changes, any biosimilar licensed under the PHS Act § 351 (k) no longer needs to contain a statement on its label indicating that it is a biosimilar. The FDA also decided that the label does not need to indicate whether a biosimilar is interchangeable with its reference product. In other words, the FDA did just what some players in the industry were afraid of: it decided to treat biosimilars like small molecule generics (at least in terms of labeling).

Like many in the industry, I agree that biosimilars should be viewed through a different lens than that of identical small molecule generics because of their molecular differences. But I, unlike some reference brand makers, find this to be one of the best possible moves the FDA could’ve made to ensure biosimilar drugs are prescribed rather than singled out as the new kids on the block — and it’s clear from the reactions of one company that this has hit close to home for reference drugmakers.

In particular, AbbVie has been quite vocal — no doubt because its Humira is predicted to lose a lot from biosimilar competition in upcoming years. According to the FDA Law Blog, AbbVie submitted a citizen petition challenging the FDA’s labeling of the first U.S.-approved biosimilar of Zarxio. As Biosimilars Law Blog outlined, the label for Zarxio followed the “generic drug” model. The label contains all the information that can be found on Neupogen’s label, as well as some new details about how users need to administer the biosimilar. But this label isn’t quite detailed enough for AbbVie. According to the company, the biosimilar label needs to do several things (if applicable), including:

  • clearly identify the treatment as a biosimilar and state that the treatment is not licensed for all the reference product’s indications
  • articulate that the indications the biosimilar can treat were determined based on extrapolation
  • clearly state that the FDA has not found the biosimilar to be interchangeable with the reference product
  • provide the data that led to the biosimilar’s licensing, as well as the information necessary to help prescribers determine any differences in data between the biosimilar and reference product studies.

The FDA has since responded to AbbVie’s petition, claiming that information about a biosimilar’s interchangeability could be found in the FDA’s recently-launched Purple Book, and, therefore, did not need to be disclosed on the label.

Obviously, this was not what AbbVie wanted to hear. Now, in a new supplement to the first petition, the company has once more expressed its displeasure at the FDA’s “indefensible” omissions of a biosimilar’s differences from its reference molecule. According to AbbVie, the reliance on the Purple Book for information on interchangeability strays from the FDA’s stringent requirement that a label include all essential prescribing information, Law360 states. The similarities between this process and the one used to determine equivalence of a generic are no doubt also causing some strife; prescribers turn to the Orange Book rather than the label to determine a generic’s therapeutic equivalence to the originator. Not only does AbbVie argue that the Purple Book is “incapable of portraying what could be a highly complicated landscape of products with varying scopes of biosimilarity and interchangeability,” but the industry also has been adamant that biosimilars be regarded as and treated differently than generics. For the FDA to rely on a similar — if not the same — procedure as generics for the dissemination of biosimilar information would go against the BPCIA’s ruling that biosimilars are different from their reference products and, as such, do not have the “same labeling” requirement as generics.  

I can see AbbVie’s concerns about making interchangeability information for prescribers only available in the Purple Book. For one, this move seems to defy the increasing cries for industry transparency. If there are subtle differences between the reference molecule and that of the biosimilar, providing the information about these differences right on the drug’s label could help promote this much-desired transparency. It could also bolster the education of prescribing doctors, which, given the results of a recent survey carried out by QuantiaMD, is desperately needed to ensure the biosimilar industry gets off the ground. For instance, a majority (67 percent) of doctors are currently unable to name a single biosimilar. (Clearly, this is going to be a problem moving forward.)

It’s perhaps also not surprising to those in the generics industry that AbbVie would want to ensure that a drug is clearly labeled as a biosimilar. At least one generics company, Momenta Pharmaceuticals, expects that these outcries have a lot to do with AbbVie’s wish to “create barriers to the development and commercialization of biosimilars.” In fact, generics companies have voiced similar concerns about brand drugmakers’ motives when it comes to the ongoing biosimilar naming debate — and I dare say they’re probably not too far off. There are certainly some big commercial motives for naming and labeling biosimilars as individual entities in comparison to their reference products.   

But I’m also slightly curious about AbbVie’s persistence, especially because reversing the FDA’s labeling decisions could have some potentially negative implications for biologics. It would seem to me that the more hoops the FDA makes prescribers jump through to find interchangeability information, the more likely prescribers are to just stick with the reference biologic. In other words, making doctors get online and seek out the Purple Book could be a deterrent for biosimilar prescriptions — but it would be a big win for brand name makers. According to the QuantiaMD survey, 94 percent of physicians have faith the biosimilar market will be valuable to healthcare. However, only a meager 17 percent of those who prescribe biologics would be “very likely” to prescribe biosimilars. Take a wild guess what their hesitations might be: safety/efficacy (which could be a moot point should comparison data be included on the label), drug substitution regulations, and information on prescribing the biosimilar vs. the branded drug. Once again, providing interchangeability information on a label would ease some concerns here. In fact, the more information about the biosimilar included on the label, the more actionable information doctors have to prescribe the biosimilar rather than the costly biologic.

I don’t wish to discredit AbbVie’s persistent arguments here. As the FDA Law Blog cleverly claimed, making biosimilars “feel like [The Scarlet Letter’s] Hester Prynne” by differentiating the label is perhaps fitting for a biosimilar. Let’s face it, biosimilars are impressive scientific and manufacturing accomplishments. I’m also a proponent of increased transparency in the industry as a whole. Given doctors’ lack of familiarity with and, therefore, concern about biosimilars, the more information about a biosimilar that is available on the label, the more likely we could see the market flourish. But perhaps AbbVie should be picking and choosing its battles; after all, getting the FDA to change its mindset on biosimilar labeling could be a big step toward pushing prescribers away from the brand name market.