United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2018_register
executive
2018-12-12
article
Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability
Notices
D09002ee1bdb7db02
D09002ee1bdb7db74
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Questions and Answers on Biosimilar Development and the BPCI Act.'' The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009'' issued April 28, 2015.
83 FR 63900
https://www.govinfo.gov/app/details/FR-2018-12-12/2018-26853
2018-26853
fr12de18-65
4164-01-P
Docket No. FDA-2011-D-0611
https://www.govinfo.gov/app/details/FR-2018-12-12/2018-26853
https://www.govinfo.gov/content/pkg/FR-2018-12-12/html/2018-26853.htm
https://www.govinfo.gov/content/pkg/FR-2018-12-12/pdf/2018-26853.pdf
3 p.
63900
63902
83 FR 63900
Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability; Federal Register Vol. 83, Issue
NOTICE
2018-26853
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-D-0611
4164-01-P
2018-26853
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Questions and Answers on Biosimilar Development and the BPCI Act.'' The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009'' issued April 28, 2015.
The announcement of the guidance is published in the Federal Register on December 12, 2018.
Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993, 301-796- 1042, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
Guidance:
Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act
,
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 83, no. 238
Office of the Federal Register, National Archives and Records Administration
2018-12-12
continuing
daily
deposited
born digital
257 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-12-12
P0b002ee19e1df02b
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr12de18
https://www.govinfo.gov/app/details/FR-2018-12-12
https://www.govinfo.gov/content/pkg/FR-2018-12-12/pdf/FR-2018-12-12.pdf
https://www.govinfo.gov/content/pkg/FR-2018-12-12/xml/FR-2018-12-12.xml
fdlp
63775
64022
DGPO
2018-12-12
2023-04-28
FR-2018-12-12
machine generated
eng
FR
FR-2018-12-12
83
238