On November 23, 2015, a group of fifteen institutional investors submitted a citizen petition to the FDA regarding biosimilar labeling (“Investors’ Citizen Petition”). The group includes investors from the public sector and labor-management, as well as faith-based investors. The Investors’ Citizen Petition is not the first citizen petition submitted regarding biosimilar labeling. In June of this year, AbbVie submitted a citizen petition arguing against the FDA’s “same labeling” approach taken when approving a label for Sandoz, Inc.’s (“Sandoz’s”) Zarxio® that was nearly identical to that of the reference product, Neupogen®. See The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling.

However, unlike AbbVie’s citizen petition, the Investors’ Citizen Petition is in favor of the “same labeling” approach used for Sandoz’s Zarxio®. The Investors’ Citizen Petition requests that (1) the FDA require all biosimilars to have the same labeling as their reference drugs and (2) the FDA conduct a public hearing to allow stakeholders to express their views on biosimilar labeling and any other issues being debated by the FDA regarding biosimilars. (Investors’ Citizen Petition at 1.)

The investors argue that the “same labeling” approach is “critically important in boosting investor confidence, signaling market certainty, and upholding the role of the FDA in determining biosimilarity and interchangeability.” (Investors’ Citizen Petition at 2.) Additionally, the investors argue that a public hearing is needed to address the following issues: (1) the implications of labeling rules on biosimilar innovation and investment in the United States; (2) the European experience with biosimilars; and (3) stakeholder views on the effect that different labeling approaches may have on prescribing, dispensing, and patient use of biosimilars. (Id.)

1. Implications of Labeling Rules on Biosimilar Innovation and Investment
First, the investors argue a public hearing should be held to allow investors to share their perspectives with the FDA regarding the impact labeling can have on potential biosimilar growth in the United States. (Investors’ Citizen Petition at 3.) The investors argue the “same labeling” approach should be adopted to foster the introduction and wide acceptance of biosimilars, which would therefore encourage companies to develop more biosimilars. (Id.) Additionally, they assert that requiring a biosimilar to have the same label as its reference product will confirm the safety and efficacy of the FDA approval process for biosimilar biologics while providing prescribers and patients with necessary information to make an informed treatment decision. (Id.)

Also, the investors argue the FDA should reject AbbVie’s proposal that biosimilars should be required to (1) include information about the clinical trials conducted by the biosimilar sponsor and (2) include information about the licensure pathway under which the drug was approved. (Id.) The investors assert that this information is available from other sources, such as the Purple Book and published peer-reviewed literature, and therefore should not have to be provided on the biosimilar’s label. (Id.) Further, the investors argue that failure to adopt the “same labeling” approach will raise safety issues, as it would inaccurately signal to prescribers that biosimilars are more dissimilar to their reference products than their moniker, biosimilars, would suggest. (Id.)

2. The European Experience With Biosimilars
Second, the investors argue a public hearing should be held to allow investors to share their experience with biosimilars in Europe. The investors point out that Europe follows a “same labeling” approach and has over twenty biosimilars on the market, none of which have reported immunogenicity issues. (Investors’ Citizen Petition at 3.) Because companies may have a global biosimilar presence, the investors argue it is important to consider European biosimilar policies to ensure consistent policies and regulations are maintained across global markets. (Id. at 4.) 

3. Stakeholder Views on Labeling
Finally, the investors argue a public hearing should be held to allow the FDA to hear stakeholders’ viewpoints on labeling. They argue that stakeholders that order, prescribe, and dispense biosimilars, as well as patients, should be allowed to share their opinions on this issue.  (Investors’ Citizen Petition at 4.) The investors assert that the “FDA would greatly benefit from hearing views from all stakeholders on the labeling issue prior to issuing proposed regulations.” (Id.)

It will be interesting to see whether the FDA will respond to the Investors’ Citizen Petition in a meaningful way and, if so, whether the investors’ arguments will persuade the FDA to adopt different “final” rules for biosimilar labeling as well as persuade the FDA to hold a public hearing.  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.