FDA Statement on New Biosimilar Framework

The U.S. Food and Drug Administration (FDA) announced new measures to advance the development of biosimilars in a letter from Commissioner Scott Gottlieb, MD. “Not all parts of the pharmaceutical market have been equally open to competition from more affordable products,” he wrote. “This is especially true for biologic medicines, which are … increasingly the backbone of modern therapy.”

While patent issues surrounding biosimilars continue, the FDA released four guidance documents on the topics in an effort to maintain efficient regulatory processes. Two of the guidance documents provide “greater clarity on scientific and regulatory considerations for the development of biosimilar and interchangeable products.” The other two documents identify how the FDA will implement a transition of these products from the drug pathway to the biologics pathway. According to the documents, the FDA seeks to transition marketing approval for biologics products to biologic licenses starting in March 2020.

In the documents, the FDA addresses the use of limited distribution systems in order to delay or derail access to reference product samples that biosimilars need for testing. “While the limited distribution programs can have a role in promoting patient safety, too many branded products are still misusing these programs as rhetorical smokescreens to hide anti-competitive behavior,” said Dr. Gottlieb. “We’re not going to be partners to these deceptions.”

The FDA said it will review study protocols from biosimilar applicants to assess whether their protocols contain comparable safety protections to those in the Risk Evaluation and Mitigation Strategies (REMS) for the reference product. The FDA will issue a letter to the reference product holder informing them that comparable protections exist, and that the FDA will not consider it to be a violation of the branded drug company’s REMS to provide the biosimilar sponsor with a sufficient quantity of the reference product to perform testing necessary to support its biosimilar application. “We’re actively evaluating how we can make it easier for biosimilar manufacturers to use reference products from outside the United States, where prices may be cheaper and reference products more accessible,” said Dr. Gottlieb.

“I know the pace of progress has disappointed some,” he said. “I’m not discouraged. I believe it will take time for this market to mature. But that doesn’t mean we don’t face critical challenges. And it doesn’t mean that we have the right policy framework to realize these opportunities. There’s more that we need to be doing – all of us.”

In the past year, the FDA approved seven biosimilar products, for a total of 15 approved products. In addition, there are currently more than 60 biosimilar development programs ongoing.