According to their commentary, Legislation Threatens Patient Confidence in Biologics, Slows Biosimilars, legislative language in the Senate’s FDA and NIH Workforce Authorities Modernization Act would impede “the one issue uniting policymakers” -- the need to improve our system for getting low-cost quality-assured therapies to patients quickly.” How? “… by exempting biologic medicines – including biosimilars, insulin, blood thinners, cancer treatments and other drugs – from having to comply with public standards for quality.”
That’s a pretty strong statement and a lot of people should (rightly) take offense. But it raises an important issue – why the vitriol?
It’s a complicated issue with many moving parts, all of them worth serious debate. For those in on the issue, the under-current renews the continuing tension between USP and FDA on many matters relative to biosimilars.
It’s important that these two institutions work together in many places and understand each other’s individual efforts -- not the least of which is the continuing evolution of the FDA’s new Purple Book.
The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act (the PHS Act). The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act.
The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated.
USP and FDA both have important roles to play. It’s a very small sandbox with very large public health implications.