One of the most important parts of launching a robust US biosimilar market and setting up the regulations to support it is to make sure the scientific framework is "bulletproof," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told senators on Thursday.
Speaking as the sole witness before the Senate Subcommittee on Primary Health and Retirement Security, Woodcock touched on a number of yet-to-be resolved issues tied to biosimilars, including the long-awaited FDA guidance on interchangeability and the difficulties behind developing, naming and labeling the new products.
The most heated exchanges came between Woodcock and Sen. Elizabeth Warren (D-MA), who seemed particularly peeved about the delay in FDA's release of a number of guidance documents, particularly on interchangeability and labeling.
"We have to get the science right. We can't have problems with the first biosimilars out of the block," Woodcock told Warren. Woodcock added that the remaining guidance documents that have yet to be issued are mostly tied to policy, rather than scientific issues. FDA in April finalized three guidance documents tied to biosimilars.
She also said FDA can't provide any specific dates for when the guidelines will be issued or when the draft guidelines will be finalized because of the complicated authorization process.
But Woodcock did single out guidance that's to be expected in this calendar year on "Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity," saying it's the third most important guidance document to get out, after interchangeability and labeling.
She mentioned that with biologics and biosimilars there can be variations "from lot to lot," so there needs to be a way to measure via analytical chemistry and statistics how much those variations matter. She also said FDA has consulted with the European Medicines Agency, "and they think our approach is sound."
Other senators, including Sen. Chris Murphy (D-CT) mentioned the fact that it took a long time to educate physicians and patients on generics, and he wondered what the agency was doing in terms of educating the public on biosimilars.
"We've laid out a plan of education campaigns and still need to determine what people need to know," Woodcock said. Woodcock noted that FDA will look to target specialty groups individually, as biosimilars won't be used generally by all practitioners. "It's a complicated issue so we have a menu of educational activities for the next several years," she added.
And as far as the naming of biosimilars, which has been a big issue lately, Woodcock stressed the importance of being able to pull the appropriate biosimilar from the market if there's an imminent problem. She also noted that FDA worked with the World Health Organization on the recent draft naming guidance for biosimilars, which she said raised a number of questions for potential commenters.
Video of the Hearing