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# Questions Raised About Biologics Interchangeability
- URL: https://www.fdaweb.com/questions-raised-about-biologics-interchangeability/
- Published: 2019-06-05T12:00:00.000Z
- Updated: 2026-09-15T01:30:45.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, #legacy-id-D5144264

Georgia State University law professor **Yaniv Heled** says a new FDA guidance explaining how drug manufacturers can develop follow-on biologics is a good step toward lowering drug costs, but may not be enough to make a real difference. Writing online for *The Conversation*, Heled [explains](http://theconversation.com/cheaper-versions-of-the-most-expensive-drugs-may-be-coming-but-monopolies-will-likely-remain-117573?utm%5Fmedium=Social&utm%5Fsource=Twitter#Echobox=1559662804) why biologics are so expensive (often costing many tens to hundreds of thousands of dollars a year) and what the FDA guidance hopes to accomplish to lower costs.

He says the 2010 Biologics Price Competition and Innovation Act only created a legal pathway for follow-on biologics and didn’t address the technical challenge of comparing an original, expensive biologic with its cheaper imitation, leaving that to FDA to figure out.

Heled says the new guidance provides instructions for proving that two products, an original biologic and the follow-on, are similar enough to be deemed substitutable. “Once FDA approves interchangeable versions of biologics, this should drive competition in biologics and, ultimately, cause their prices to drop,” he writes…. “But concerns remain that FDA’s guidance might not be enough to drive down prices significantly. Development of similar biologics is estimated to cost about $100 million to $200 million. This is much higher than the development of generic drugs, which is estimated to cost, typically, between $1 million and $5 million. There are not very many companies with the kind of facilities, expertise, and money necessary to develop interchangeable versions of biologics and chaperon them through FDA’s approval process. As a result, it is quite possible that there will not be a lot of companies able to compete.”

He also notes that the guidance applies only to protein products and there is still no clear regulatory path for FDA to approve interchangeable versions of some of the most expensive biologics, such as gene therapies.