An Eventful May Upcoming for Biosimilars

The Food and Drug Law Institute held May 2-3, in Washington, DC, offered a few nuggets of information that are well worth mentioning here and serve as a reminder of some of the important events to happen later this month.

Janet Woodcock
Janet Woodcock, Director of CDER at FDA

At the meeting, FDA’s Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research, confirmed that the long-awaited final guidance for biosimilar interchangeability will be released by the user fee goal date of May 17, 2019. This much-delayed document should close the door on requirements for obtaining the interchangeability designation, and may well allow biosimilar makers to move towards this elusive goal.

Dr. Woodcock also emphasized that interest in biosimilars from prospective manufacturers is far from dead: “As of April 2, 2019, 77 programs (for 36 different reference products) were enrolled in the Biosimilar Product Development Program to discuss development of proposed biosimilar products or interchangeable products,” she stated. Of course, this figure includes products that are not yet off-patent. Yet it is a hopeful number that implies fairly broad interest from industry players.

As part of the Biosimilar Action Plan, HHS Commissioner Alex Azar included attempts to speed drug approvals and access through the use of “skinny labels.” That refers to granting approvals to only a subset of indications held by the reference product. This draft guidance will be issued soon.

Furthermore, revised draft guidance on comparative analytical assessments are to be released by the user fee goal date of May 21, 2019. This document may bring some clarity to the potential use of a global comparator, which could obviate the need for bridging studies for an EU-licensed reference product to a US-licensed agent. We’ll have to wait and see on this one.

On May 13, 2019, a Part 15 hearing will be held on “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products.” Dr. Woodcock said that FDA will be seeking input on “biosimilar and interchangeability development requirements for insulins, use with insulin pumps and over-the-counter insulins, aspects of patient experience important in evaluating proposed biosimilar, and interchangeable insulins.

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