The FDA has revealed a set of measures designed to increase the availability of biosimilars in the U.S. and in turn reduce the price of biologic medicines after they lose patent protection.
In new draft guidance, the FDA has taken steps to reduce clinical testing burdens for biosimilars and to categorize all approved biosimilars as “interchangeable,” which means a pharmacist can freely substitute the biosimilar for a more expensive brand-name reference treatment.
The FDA pointed out that, while biologic medicines make up only 5% of the prescriptions written in the U.S., they account for 51% of the country’s drug spending.
The agency added that Europe has approved more than twice as many biosimilars as the U.S. and that biosimilars are in development in the U.S. for only about 10% of branded biologic treatments that will lose patent protection in the next decade.
Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. pointed out in a press conference that the generic drug market has operated largely as it was designed in the 1984 Hatch-Waxman Act, effectively reducing prices for “traditional chemistry-based drugs.”
But the development of the market for knockoff biologic treatments has been hindered by the hurdles companies have to negotiate to gain approval for their copycat versions of branded biologics.
“When Congress wrote the Biologics Price Competition and Innovation Act, the pharmaceutical industry rigged the rules,” RFK Jr. said. “Between 2007 and 2009, big pharma spent hundreds of millions of dollars lobbying to make biosimilar approvals far more difficult and expensive.”
Biosimilars have a different pathway to approval because biologic treatments are more complex as they are derived from living organisms such as bacteria, yeast and animal cells.
Despite this complexity, many more biosimilars would have been developed were it not for the “serious onerous requirements the FDA has had making the process long and expensive for the makers of these biosimilar equivalents,” FDA Commissioner Marty Makary, M.D., added in the press conference.
“We have 76 (biosimilars) that we’ve approved in 10 years—probably should have been 200 or 300,” Makary said. “This reform will take the five- to eight-year time frame to bring a biosimilar to market and cut it in half.”
Makary added that the new measures would cut the average development cost for a biosimilar in half.
Makary said the FDA also proposes to eliminate switching studies that are required to gain “interchangeable” status for biosimilars.
The Biosimilars Forum—an organization that promotes the development and use of the products in the U.S.—applauded the FDA effort.
“This decisive action from the FDA is also timely considering the looming ‘biosimilar void,’ which is a pressing, urgent situation that threatens the very viability of our industry,” Juliana Reed, executive director of the Biosimilars Forum, said in a statement. “This biosimilar void threatens to leave patients without affordable alternatives, forcing them to rely on high-cost brand-name drugs which will only worsen the healthcare affordability crisis.”
This isn’t the first time the FDA has criticized Big Pharma over its efforts to tamp down the availability of biosimilars. In 2018, then-FDA Commissioner Scott Gottlieb, M.D. lashed out at “unacceptable” tactics—such as rebates and litigation—used by drugmakers to limit competition from biosimilars.
Streamlining access to biosimilars could help President Donald Trump achieve his goal of reducing drug prices in the U.S. Over the past several weeks, the administration has sought to do just that through a series of so-called “most favored nation” (MFN) pricing deals with certain Big Pharma companies. Trump’s MFN strategy, laid out in a sweeping executive order in May, essentially seeks to tie the prices of branded pharmaceuticals in the U.S. to costs in other economically advanced countries.
Companies like Pfizer and AstraZeneca have so far agreed to provide certain medicines at discounted prices under agreements with the Trump administration, although the extent to which these arrangements will move the needle on high drug costs for average Americans remains to be seen.