5 Things to Know About the FDA's Biosimilar Action Plan

Since biosimilars gained a US approval pathway as part of the Affordable Care Act, these follow-on drugs have been widely seen as a key way to address the problem of high-cost biologic drugs. However, cost savings have been disappointing, as only 12 biosimilar products have been approved to date, and just 4 have become commercially available. That’s a reality that led FDA Commissioner Scott Gottlieb, MD, to call the US market for biosimilars “anemic.”

To address the problem of lagging price competition, the FDA recently released a long-promised document, the Biosimilar Action Plan. Here are 5 key things to know about the plan.

1. The plan would give biosimilar makers far more regulatory clarity.

In order to help more biosimilars successfully navigate the approval process, the FDA says that it will create review templates specifically for biosimilars and the data needed to meet approval standards, and it will produce an index of critical quality attributes that are used in comparing proposed biosimilars to their reference products.

The plan also indicates that final, draft, or revised guidance is forthcoming on topics including product exclusivity, evaluation of analytical similarity, and postapproval manufacturing changes. Finally, the FDA will update its Purple Book to include more information patent exclusivity on biologic products.

2. The FDA is also exploring ways to address anticompetitive behavior in the market.

Because product approval is only one hurdle in bringing a biosimilar to market, the FDA has signaled that it is willing to work more closely with the Federal Trade Commission to address any practices that businesses are using to thwart competition from biosimilars, such as striking contracts with pharmacy benefit managers that require health plans to exclude biosimilars from formularies.

Attorney Robert Cerwinski, JD, partner at Goodwin, told The Center for Biosimilars^®, a sister publication of The American Journal of Managed Care^®, that the FDA appears to be “a little bit more activist” in its new approach to enhancing competition. “In the past, FDA has not always wanted to weigh in to such disputes,” he said.

3. Industry has been optimistic about the plan.

The Biosimilars Forum, which represents biosimilar developers, called the plan an “important step,” and praised Gottlieb for being a champion of biosimilars. Executives form Pfizer told The Center for Biosimilars^® that the document addresses most of the issues on which the company has sought greater clarity.

4. New guidance was launched in conjunction with the plan, but not the guidance many have been waiting for.

Concurrent with the plan’s publication, the FDA finalized its guidance on labeling for biosimilar products. While the document was a welcome addition to the growing body of guidance from the FDA on biosimilars, stakeholders are still waiting for final guidance on an even more important topic: interchangeability.

While federal law provides for interchangeable biosimilars—which are products that can be substituted for their reference drugs at the pharmacy level in much the same way that a generic might be substituted for a brand-name small-molecule product—so far, the FDA has not provided final guidance on how to demonstrate interchangeability.

5. Stakeholders will have their say in September.

On September 4, 2018, the FDA will hold a public hearing on the plan, and is asking for feedback on how the agency can use its existing statutory authority to regulate products in order to address issues concerning the current lack of competition in the US market. Those who are unable to attend the hearing in person have the option to livestream the event, and electronic comments may be submitted on the Federal Register until September 21, 2018.