FDA outlines steep hurdles, early fees for first-gen biosimilars

Demonstrating once again that developing biosimilars will be neither cheap nor easy, the FDA says that it plans to charge the same user fees for a biosimilar application as it does any other new biologic that comes its way. And it's planning on assessing those charges early on in the development process, as regulators and developers blaze a regulatory trail with the first generation of pioneering projects.

Reviewing these biosimilar programs, says the agency in a new proposal, will be "comparably complex, technically demanding, and resource-intensive" as a brand drug. And the agency says that as this new pathway opens up for developers its services will be needed well before the marketing application hits its desk. As a result, reports The Hill, the FDA expects to charge $150,000 a year during development and then subtract the total from the final tally for an approval.

"Given that the approval pathway for biosimilar and interchangeable biological products is new," notes the agency, "FDA services are most critical for continued and successful development of biosimilar and interchangeable biological products during the investigational stage prior to submission of a marketing application."

The proposal makes clear that drug companies are already clamoring for insight on product development, and will likely continue to pose a blizzard of questions early on. And the FDA faces a tough challenge getting up to speed quickly. "For example, characterizing biological products for the purpose of determining biosimilarity or interchangeability is challenging because the molecules of biological products tend to be much larger and have a far more complex spatial structure than small-molecule drugs."

Separately, the FDA's Janet Woodcock told a conference that a full set of biosimilar guidelines will be out later this year. And human testing, she adds, will not be required for all of them.

"It depends on how confident you can be of the absolute sameness to the innovator product," Woodcock said. "There's a spectrum ... some will get much closer than others in your ability to characterize them."

- here's a link to the FDA's user fee proposal
- check out the story from The Hill
- read the report from Bloomberg
- here's the story on Woodcock's remarks from Reuters