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# BPCIA and Biosimilar Development Q&A
- URL: https://www.fdaweb.com/bpcia-and-biosimilar-development-q-a/
- Published: 2020-11-19T12:00:00.000Z
- Updated: 2026-09-14T16:37:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148127

FDA has published a draft guidance, *Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act*, with answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act (BPCIA) of 2009\. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/biosimilarity-and-interchangeability-additional-draft-qas-biosimilar-development-and-bpci-act?ref=fdaweb.com) says the question-and-answer format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable products, we well as describe the agency’s interpretation of certain statutory requirements added by the BPCIA.

“FDA believes that guidance for industry that provides answers to commonly asked questions regarding FDA’s interpretation of the BPCIA will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products,” the guidance says. “In addition, these Q&As respond to questions the agency has received from applicants regarding the submission of biologics license applications for biosimilar and interchangeable products. FDA may provide additional Q&As through draft guidance as appropriate.”