On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA has adopted the same labeling approach as used for generic pharmaceutical drugs. However, AbbVie argues in its petition that “[b]iosimilars are not generic drugs and should not be labeled like generic drugs.” (AbbVie Citizen Petition at 1.)
AbbVie’s petition addressed the FDA’s approved labeling of the first approved biosimilar product, Zarxio® by Sandoz. The FDA followed a “same labeling” approach, wherein the approved labeling for Zarxio® is nearly identical to that of the reference product, Neupogen. According to AbbVie, “[i]t would be legally unsound for FDA to adopt a ‘same labeling approach’ to biosimilars, as the Agency has done with respect to Zarxio.” (AbbVie Citizen Petition at 3.) AbbVie states: (1) the “same labeling” approach is inconsistent with the BPCIA; (2) the “same labeling approach” would result in labeling that omits material information necessary for safe and informed prescribing; and (3) the FDA violated the Administrative Procedure Act (“APA”) when it abandoned the labeling approach taken in the Draft Scientific Guidance. Id.
1. The “Same Labeling” Requirement is Inconsistent with the BPCIA
In its petition, AbbVie pointed out that Congress established a distinct approval pathway for biosimilars and that, as stated by the Director of the Center for Drug Evaluation and Research, it is “impossible to demonstrate that [a follow-on biological product] is identical to” a previously approved product. (AbbVie Citizen Petition at 4.) Therefore, since the BPCIA only requires a showing of sufficient similarity, not exact equivalence, between the biosimilar and the reference product, it should not use the “same labeling” requirement.
Additionally, AbbVie pointed out that Congress selectively borrowed some, but not all, provisions from the ANDA pathway when drafting the BPCIA. One of the ANDA provisions Congress excluded from the BPCIA was the “same labeling” requirement. In view of Congress’ decision to exclude the “same labeling” requirement from the BPCIA, the FDA’s decision to apply it in labeling biosimilars conflicts with the novel licensing scheme established by the BPCIA and is therefore “legally unsound.” (AbbVie Citizen Petition at 6.)
2. The “Same Labeling” Requirement Omits Material Information
AbbVie further argued that the “same labeling” requirement does not provide the transparency needed in biosimilar labeling to enable informed prescribing and to dispel widespread misconceptions about biosimilar products as being “generic” or “biogeneric” products. (AbbVie Citizen Petition at 9.) In support of this argument, AbbVie points to surveys regarding physician familiarity with biosimilars. For example, a June 2014 survey found that 39 percent of surveyed physicians could not define or had not heard of biosimilars. Because of this unfamiliarity with biosimilars, AbbVie argued that the “same labeling” requirement would not be sufficient and, instead, the FDA must ensure the labeling of biosimilars provides prescribers with information they need to understand the important differences between the biosimilar and its reference product.
3. The FDA Violated the APA When It Abandoned the Draft Science
Guidance’s Labeling Approach
In February 2012, the FDA’s Draft Science Guidance’s biosimilar labeling stated the labeling should include clear statements regarding the biosimilar product that advises whether the product is a biosimilar and discloses whether it is interchangeable with its reference product. In this Guidance, the FDA stated this information is “necessary for a health professional to make prescribing decisions.” (AbbVie Citizen Petition at 18.)
However, in April 2015, the final version of the guidance contained no discussion of biosimilar labeling and instead omitted this entire discussion on labeling. Because of this, AbbVie argued in its petition that the FDA’s decision to remove the biosimilar labeling discussion and change course was “arbitrary and capricious” and therefore violated the APA. (AbbVie Citizen Petition at 22.) Because the FDA initially stated that clear statements regarding labeling were necessary for safe prescribing, its abandoning of the proposed labeling without any comment was improper.
4. AbbVie’s Proposed Labeling Requirements for Biosimilars
For the reasons stated above, AbbVie requested that the FDA require that biosimilar labels contain: (1) a clear statement the product is a biosimilar, that the biosimilar is licensed for fewer than all the reference product’s conditions of use (if applicable), and that the biosimilar’s licensed conditions of use were based on extrapolation (if applicable); (2) a clear statement that the FDA has not determined the biosimilar is interchangeable with the reference product (if applicable); and (3) a concise description of the pertinent data developed to support licensure of the biosimilar, along with information adequate to enable prescribers to distinguish data derived from the biosimilar’s studies from the reference product’s studies. (AbbVie Citizen Petition at 1.)
It will be interesting to see whether the FDA will respond to AbbVie’s Citizen Petition in a meaningful way and, if so, whether AbbVie’s arguments will persuade the FDA to adopt different “final” rules for biosimilar labeling. In any case, the FDA does need to provide a final decision regarding biosimilar labeling, as more biosimilars head toward approval.
K&L Gates LLP will continue to follow any developments.
