FDA's bold move could slash drug costs for millions
The FDA is shaking up how biosimilar drugs—affordable versions of pricey biologic meds for things like cancer and autoimmune diseases—get approved.
Instead of requiring long, expensive clinical trials, the agency wants to rely more on lab testing, which could significantly reduce development time and save a lot of money.
Streamlining the process
Another big change: the FDA plans to make it simpler for biosimilars to earn "interchangeable" status.
This could allow pharmacists to substitute these lower-cost alternatives more easily, increasing patient access.
The hope? More options for patients, less hassle, and real progress on lowering drug prices.
Why it matters
Biologic drugs make up just 5% of prescriptions but eat up over half of US drug spending.
Even though dozens of biosimilars have been approved, they haven't caught on much yet.
The FDA's new approach aims to open up the market so more people can actually afford these life-changing treatments.