> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Q & A Guide on Biosimilar Development
- URL: https://www.fdaweb.com/q-a-guide-on-biosimilar-development/
- Published: 2021-09-17T12:00:00.000Z
- Updated: 2026-09-14T17:15:06.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150166

*Federal Register* notice: FDA has made available a [final guidance ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-biosimilar-development-and-bpci-act-guidance-industry?ref=fdaweb.com)entitled *Questions and Answers on Biosimilar Development and the BPCI Act*. The document is intended to inform prospective applicants about the development of proposed biosimilars and proposed interchangeable biosimilars. It also describes FDA’s interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009\. The guidance revises a 2018 document under the same title. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-20255.pdf?ref=fdaweb.com).