Search
USFDA Guidance on Biosimilar Development and the BPCI Act: Key Regulatory Considerations
The development of biosimilar and interchangeable biological products is an important part of improving access to biological medicines. To support this process, the U.S. Food and Drug Administration (FDA) has issued guidance documents that clarify regulatory expectations under the Biologics Price Competition and Innovation Act (BPCI Act) . Two key FDA guidance documents provide detailed explanations through a question-and-answer format to help sponsors understand the regulat
Sharan Murugan
4 hours ago4 min read