FDA Proposes Streamlining Biosimilar Development Process to Lower Health Care Costs

The US Food and Drug Administration (FDA) has announced plans to simplify the development process for biosimilars, a type of medication that mimics complex biologic medicines. The proposed change would eliminate the need for lengthy clinical trials, allowing biosimilars to be approved more quickly. This move is expected to significantly lower health care costs, particularly for patients with cancer, autoimmune diseases, and rare disorders. According to the FDA, biologic drugs account for 51% of total US drug spending, despite making up only 5% of prescriptions.

Key Takeaways:

• The FDA proposes ending the requirement for clinical trials for biosimilars, which can take up to three years and cost $24 million.
• Biosimilar manufacturers would instead use analytical testing to demonstrate biosimilarity.
• The FDA estimates that 10% of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development.
• The agency has approved 76 biosimilars to date.
• Commissioner Marty Makary states that biosimilars have the potential to significantly lower health care costs by streamlining the development process.
• The draft guidance is open for comment for 60 days.
• The FDA has also introduced an initiative to simplify the generic medicine development process.

Statistics:

• 51% of total US drug spending is attributed to biologic drugs, despite only 5% of prescriptions.
• Biologic drugs account for 10% of prescriptions but account for 51% of total drug spending.
• The cost of clinical trials for biosimilars can reach up to $24 million.
• 76 biosimilars have been approved by the FDA to date.
• Only 10% of biologic drugs expected to lose patent protection in the next decade currently have a biosimilar in development.

Sources:

• The Trump administration's latest effort to lower drug costs is the drugmaker's response to the public's growing frustration with expensive medications.
• A comparative analytical assessment (CAA) is generally more sensitive than a Comparative Effectiveness Study (CES) to detect differences between two products.
• According to the FDA, biologic medications made with or isolated from living organisms include cells.
• Eligible drugs also must be manufactured in the U.S. using domestically sourced active pharmaceutical ingredients (APIs).