09-Oct-2026
Intelligence Overview
The U.S. Food and Drug Administration (USFDA) has issued the revised guidance document “Questions and Answers on Biosimilar Development and the BPCI Act (Revision 4)” in October 2026. The guidance was developed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
The document provides regulatory clarification for sponsors developing biosimilar and interchangeable biosimilar products under Section 351(k) of the Public Health Service Act.
Key Highlights
- Biosimilarity and interchangeability: Clarifies regulatory considerations for demonstrating biosimilarity and interchangeability with an FDA-licensed reference biological product.
- Product development: Addresses formulation differences, delivery devices, container closure systems, dosage forms, strengths, and routes of administration.
- Regulatory submissions: Provides guidance on requirements for Biologics License Applications (BLAs), including relevant supporting data and information.
- Exclusivity considerations: Covers reference product exclusivity and orphan drug exclusivity considerations relevant to biosimilar development.
Regulatory Significance
This guidance serves as a reference for pharmaceutical and biotechnology companies planning biosimilar development and regulatory submissions in the United States. It supports a better understanding of FDA expectations and the regulatory considerations associated with developing biosimilar and interchangeable products.
Source: https://www.fda.gov/media/119258/download https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-biosimilar-development-and-bpci-act