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Questions and answers on biosimilar development and the BPCI Act
Questions and answers on biosimilar development and the BPCI Act
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body. - Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, September 2021
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Biosimilar Pharmaceuticals
Drug Development
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States. - Genre(s):
- Technical Report
- Abstract:
- This guidance document provides answers to common questions from prospective applicants and other interested parties regarding the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and interchangeable biosimilars, 2 as well as describe FDA’s interpretation of certain statutory requirements added by the BPCI Act. The BPCI Act created an abbreviated licensure pathway in section 351(k) of the Public Health Service Act (PHS Act) for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act (Pub. L. 111–148) (ACA)). FDA believes that guidance for industry that provides answers to commonly asked questions regarding FDA’s interpretation of the BPCI Act will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products. In addition, these Q&As respond to questions the Agency has received from applicants regarding the submission of biologics license applications (BLAs) for biosimilar and interchangeable products. FDA intends to update this final guidance document to include additional Q&As as appropriate.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (ii, 24 pages)).
- NLM Unique ID:
- 9918351277506676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918351277506676