A Closer Look at New FDA Guidance Removing Barriers to Biosimilar Development
The FDA's new guidance streamlines biosimilar development, reducing costs and regulatory hurdles and potentially enhancing market access and affordability.
This update supersedes the agency’s 2015 guidance and reflects its evolving scientific approach to biosimilar evaluation. By prioritizing analytical studies, the FDA aims to reduce both the time and cost of biosimilar development.
Historically, biosimilar development has been slowed by complex, costly regulatory requirements. Clinical Endpoint Studies (CESs) have represented a significant bottleneck—both financially and logistically.
The FDA’s draft guidance emphasizes that advanced analytical technologies can now detect minor differences between highly purified proteins more precisely than clinical trials.
Author's summary: FDA guidance simplifies biosimilar development.
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