Insurers, PBMs nudge FDA to finalize interchangeability guidance
- More than a dozen healthcare organizations, including the Campaign for Sustainable Rx Pricing (CSRxP), are calling for Food and Drug Administration Commissioner Scott Gottlieb to finalize guidance on interchangeable biosimilars.
- The letter writers believe that creating a final form of the guidance, which has remained in draft form for over eighteen months, will increase competition for biologics and improve patient access to affordable versions of the drugs.
- Fewer than 2% of people in the use take biologic drugs, but biologics make up over 40% of the prescription drug spending in the U.S. and account for the fastest-growing segment.
Biologic drugs are often expensive, driven by high R&D costs. According to analysis from the RAND Corporation last year, introducing biosimilar versions of some of biologics could cut healthcare spending by as much as $54 billion over the next decade.
The FDA has been working to build a biosimilars market while still encouraging innovation. This includes the Biosimilars Action Plan, launched this July, which aims to make the approvals process more efficient for generic, biosimilar and interchangeable alternatives by reducing the time and uncertainty associated with drug development. In theory, the plan could result in more competition on the market and therefore lower prices — a key talking point for Gottlieb.
However, things aren't moving fast enough for the payers, trade bodies and patient groups that have signed the letter to Gottlieb, urging him to increase marketplace competition by finalizing the Considerations in Demonstrating Interchangeability With a Reference Product draft guidance. The document provides recommendations on the process by which a biosimilar manufacturer will obtain an interchangeable designation for their copycat, and has been in draft form since January 2017. Interchangeable designation would allow the biosimilar to be substituted for the reference product without prescriber permission.
"In the small molecule market, the ability to substitute more affordable, but equally effective, generics for brand drugs has been extremely successful in reducing drug costs," the letter states. "However, keeping the current interchangeability guidance in draft form creates significant uncertainty in the biologics market that could discourage similar levels of substitution for the highest cost products."
It also raises the concern that maintaining the guidance in draft form "creates significant uncertainty in the biologics market that could discourage similar levels of substitution for the highest cost products."
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