The U.S. Food and Drug Administration (FDA) has unveiled the direction of a new guideline that will greatly streamline the approval process for biosimilars. The aim is to cut unnecessary clinical trials to lower development costs and reduce barriers to market entry.
On the 29th (local time), the FDA released a draft of new clinical trial standards to be applied when assessing how equivalent a biosimilar is to an original drug. The key is to simplify procedures and allow the omission of comparative clinical efficacy studies (CES) that are not strictly necessary. The final guidance is expected to be confirmed within three to six months.
The move is part of U.S. President Donald Trump's drug price reduction policy. Trump signed an executive order in April to streamline approval procedures for generics and biosimilars. The goal is to expand the introduction of copycat versions of original drugs to lower people's out-of-pocket costs for medicines.
Generics and biosimilars are both copies that replace original drugs whose patents have expired. However, because generics are made by synthesizing chemical ingredients, it is possible to make an identical drug, while biosimilars are protein therapeutics produced by culturing cells, making manufacturing and clinical testing much more complex. Even slight differences in production conditions can change quality, so development takes more time and expense.
The goal of the FDA's new guidance is to simplify biosimilars to the level of generics to lower drug prices and promote competition. Biologics currently account for only 5% of all prescriptions, but make up more than half (51%) of drug spending. According to the FDA, 76 biosimilars have been approved so far, but among original drugs nearing patent expiration, only 10% are actually being developed as biosimilars.
The FDA said, "Cumbersome approval procedures are blocking market entry," adding, "We will cut development costs by up to 90% through the new guidance." Previously, comparative clinical trials alone took an average of one to three years and about $24 million (346 billion won). However, there had been criticism that they were inefficient because they were not very accurate at detecting differences in efficacy in practice.
Under the new guidance, biosimilar developers can demonstrate differences in efficacy through cell-based experiments instead of human clinical trials. Previously, a "switching test," in which the original drug and the biosimilar are alternated to verify equivalence, was also required, but going forward most of these procedures will be omitted.
In addition, most animal toxicity tests, immunogenicity tests, and efficacy tests will be abolished or waived. Even if a drug is developed under another country's standards, it can receive approval in the United States as long as equivalence is proven.
U.S. Health Secretary Robert F. Kennedy Jr said, "This reform is a key measure to lower drug prices and expand competition," adding, "As complex procedures disappear, more affordable treatments will come to market."
FDA Director General Marty Makary said, "Biosimilars have the potential to significantly reduce medical costs for patients with cancer, autoimmune diseases, and rare diseases," emphasizing, "We will use this streamlining to improve patient access."
Starting with this overhaul, the FDA also plans to push for limits on overlapping patents for original drugs and harmonization of international standards. The agency said it aims to ensure patients in each country can receive treatment more affordably and equitably.
The policy change is also expected to be a boon for Korea-based corporations that have entered the U.S. market. Samsung Bioepis and Celltrion have already launched multiple biosimilars in the United States or are about to begin sales. An industry official said, "If the approval process is shortened, the clinical burden will ease and product development will speed up," adding, "The competitiveness of Korea-made biosimilars in the U.S. market will be further strengthened."