The Ever-Expanding Biosimilar Labeling Debate – Institutional Investors Offer their Opinion and Request FDA to Hold a Hearing

December 11, 2015

By James C. Shehan

In a citizen petition (Docket No. FDA-2015-P-4529) posted earlier this week, a group of fifteen institutional investors asked FDA to require that all approved prescription drug labeling for biosimilar and interchangeable biological products follow the “same labeling” approach that the agency applied to Sandoz's Zarxio and to hold a Part 15 public hearing on this issue as well as any other related issues being debated by the FDA and connected to biosimilars.

The investors want FDA to make two decisions about the labeling of biosimilar and interchangeable products: 1. That the label not contain information about the clinical trials conducted by the biosimilar sponsor; and 2. That the label not indicate that the product was approved under the biosimilar pathway. The investors note that an AbbVie citizen petition (Docket No. FDA-2015-P-2000) from this summer (see our post here) requested FDA to take the opposite actions. Repeating arguments made by others, the investors assert that the information that AbbVie wants in the label is available elsewhere from a “multitude of other sources including the Purple Book, FDA’s own documents regarding licensure of the product, and published peer-reviewed literature. The investors also argue that European experience with biosimilars demonstrates that “same labeling” is not incompatible with patient safety.

The stated motivation for the requested labeling actions is that biosimilars are “an attractive investment opportunity” and a safe alternative to specialty drugs “whose cost threatens the financial sustainability of the markets” in which the investors operate. The investors are concerned that labeling issues may hinder biosimilar growth in the marketplace, that “[p]olicies that … hamper the introduction or wide acceptance of biosimilars” will discourage the development of biosimilars, and that consequently investors such as themselves will lose out on the investment opportunity of biosimilars.

The investors want the requested hearing to cover three topics: 1. The implications of labeling rules for biosimilar innovation and investment in the U.S.; 2. The European experience with biosimilars, including "same labeling," "patient tracking," and patient safety; and 3. Stakeholder views on how different approaches to labeling may affect prescribing, dispensing, and patient use of biosimilars and interchangeable biologic products. They suggest that prescribers, dispensers, patients and investors should be invited to attend, and that the European experience with biosimilars be reviewed in detail.

The investors state that “to date there has not been an opportunity” for the kind of discourse offered by the suggested hearing. FDA did hold a hearing in May 2012 (transcript here) that covered existing biosimilar draft guidances and a whole host of issues regarding BPCIA implementation. But perhaps the agency will be open to another hearing, given the ever-expanding roster of parties interested in biosimilar issues.

Categories: Biosimilars