FDA's Eva Temkin Discusses Biosimilar Approvals at ACI

Eva Temkin, acting director for policy at the Office of Therapeutic Biologics and Biosimilars (OTBB), provided a snapshot of how the FDA's new office is faring in her keynote talk at the American Conference Institute’s 11th Summit on Biosimilars & Innovator Biologics.

The OTBB was established in 2018 to help usher the development of biosimilars and thereby lower health care spending and improve patient access. “What we really wanted to do was say, ‘We’re committed to this. We recognize that there are a lot of things that the agency can do to help this marketplace grow and become stable,’” Temkin said in the discussion that was moderated by Amanda Hollis, JD, a patent litigator with Kirkland & Ellis of Chicago.

One of the OTBB’s missions was to explore the use of data based on studies of reference products abroad to help bring down the development cost for biosimilar companies seeking to launch products on the US market, where the emphasis has been on doing local studies with locally sourced reference product material.

Hollis noted in her questions that reference product sourcing for US biosimilar applications can amount to almost half the cost of developing biosimilars for this marketplace.

Temkin noted that broadening the scope of resources available to biosimilar manufacturers in this context remains, very much, a work in progress. “I think we have made some progress and we’re still working on it,” she said. Discussions with foreign regulators are a part of this ongoing effort she said.

The FDA is tracking roughly 570 drug development programs underway related to potential coronavirus disease 2019 (COVID-19) therapies and has reviewed 270 trials. The pandemic has caused a massive shift in FDA priorities, Hollis noted, in a series of questions about priorities, resources, and election year politics.

Temkin responded that the resources at the OTBB remain adequate to the task of reviewing biosimilar applications, although she is “always” looking to hire more staff. The office currently has a staff of about 24, including legal and scientific professionals.

Since the beginning of 2020, the FDA has approved 2 new biosimilars, down from 10 last year; 28 have been approved since 2015. Currently there are about 90 biosimilar development projects for roughly 35 reference products, Temkin said.

With so much work on the OTBB’s plate, Hollis asked how the OTBB prioritizes these projects and decides which to review first. “As with a lot of things in government, there are limited resources and a lot of needs. One thing we take very seriously is to get stakeholder input in how we prioritize,” Temkin responded.

Hollis also asked whether patents and pending patent expirations play any role in the FDA’s decisions on which product development projects to prioritize. Temkin said that is not a central focus at the FDA. “If that is something that folks feel is something that should be taken into consideration, I would certainly encourage people to submit comments.”

A current goal at the OTBB is improving the efficiency of the biosimilar and interchangeable biosimilar approval process, and Temkin’s office has sought to create a “more tangible understanding” of what the scientific needs are for granting approvals for biosimilars, and this has included making clear what types of evidence are not acceptable for the approval of biosimilars, she said.

Reference

Temkin E, Hollis A. Biosimilars and interchangeable products: insights on FDA's perspective on implementation. Presented at: ACI 11th Summit on Biosimilars & Innovator Biologics. September 23, 2020.