IGBA Asks FDA to Waive Bridging Study Requirements for Biosimilars

The International Generic and Biosimilar Medicines Association (IGBA) recently sent a letter to HHS Secretary Alex Azar applauding the administration’s ongoing efforts to lower drug prices—as well as the FDA’s prioritization of improving the efficiency of biosimilar and interchangeable product development—and asking for a key change to the biosimilar approval process.

Currently, if a biosimilar developer were to use a reference product licensed in a regulatory jurisdiction outside of the United States, the developer would not only need to show that the product was approved under similar scientific and regulatory standards to those held by the FDA, but also supply data from bridging studies to demonstrate the comparability of the US- and non—US-licensed reference products.

Within their letter, the IGBA asks the FDA to waive the requirement for such bridging studies, saying that bridging studies not only add hundreds of thousands to millions of dollars to development costs, but also add no scientific value to the regulatory process. Furthermore, they argue, because these trials are not necessary, they are unethical.

IGBA offered its own solution, stating that the bridge between the US-licensed reference product and the non-US licensed reference can be established without the use of expensive bridging studies, and called on the FDA to develop a concept of a global comparator product that would allow for a waiver of bridging studies.

The comparator would be the reference product used for head-to-head similarity or comparability studies with a biosimilar candidate, and would be authorized in a jurisdiction that has a well-established regulatory framework, experience with evaluation of the biotherapeutic products, and post-marketing surveillance activities. If the product has the same active pharmaceutical ingredient as the US-licensed reference product and was approved on essentially the same original data package as the US-licensed product, and if confidentiality agreements between regulatory agencies that provide a framework for cross-checking product information, then bridging studies could reasonably be waived.

“This constitutes an important and effective development tool in reducing the development costs for biosimilars and interchangeable products, will increase competition and hence improve access to these live-saving treatments,” read the letter.

IGBA stated that it will follow up with both the FDA and the EMA to share an internal mapping of bridging study requirements by regulatory agencies around the world.

In fact, the potential for the FDA to do away with bridging studies is not an entirely novel idea. In an interview in February 2018, FDA Commissioner Scott Gottlieb, MD, said that he was exploring the possibility.

“I have lawyers now looking at this,” said Gottlieb. The FDA had been looking into the issue for a few months and he noted that it may be “…hard for us to get there without legislation, but we’re not done looking at this.”