Federal Register - September 20, 2021
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Source: Federal Register
Federal Register / Vol. 86, No. 179 / Monday, September 20, 2021 / Notices FOR FURTHER INFORMATION CONTACT:
Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993, 301796
1042, Sandra.Benton@fda.hhs.gov or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 209930002, 240
4027911, Stephen.Ripley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background FDA is announcing the availability of a revised final guidance for industry entitled Questions and Answers on Biosimilar Development and the BPCI
Act. The Q&A format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, and also describe FDAs interpretation of certain statutory requirements added by the BPCI Act.
The BPCI Act created an abbreviated licensure pathway in section 351k of the PHS Act 42 U.S.C. 262k 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. 111148. FDA
believes that guidance for industry that provides answers to commonly asked questions regarding FDAs interpretation of the BPCI Act will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products. FDA
intends to update this guidance to include additional Q&As as appropriate.
FDA issues biosimilar Q&A guidances that contain Q&As about biosimilar and interchangeable products. This final guidance document contains all Q&As that are in final form. The November 2020 draft guidance entitled Biosimilarity and Interchangeability:
Additional Draft Q&As on Biosimilar Development and the BPCI Act Additional Draft Q&A Guidance and the draft guidance entitled New and Revised Draft Q&As on Biosimilar Development and the BPCI Act Revision 3 New and Revised Draft Q&A Guidance contain draft Q&As.
After FDA has considered any comments on the Q&As contained in the draft guidances, received during the relevant comment period and, as appropriate, incorporated suggested
changes to the Q&A, individual Q&As will be moved to the final guidance document. This final guidance document contains Q&As that have been through the public comment process and reflects FDAs current thinking on the topics described.
This guidance document revises the final guidance document entitled Questions and Answers on Biosimilar Development and the BPCI Act to clarify and update certain Q&As and add additional Q&As. For certain Q&As, FDA updated the Q&A by referring the reader to a separate guidance document that provides additional information on the topic. In addition, a Q&A may be withdrawn and removed from the Q&A
guidance documents if, for instance, the issue addressed in the Q&A has been addressed in a separate FDA guidance document.
FDA has maintained the original numbering of the Q&As used in the December 2018 final guidance, Questions and Answers on Biosimilar Development and the BPCI Act, the December 2018 draft guidance, New and Revised Draft Q&As on Biosimilar Development and the BPCI Act Revision 2, and the Additional Draft Q&A Guidance.
TABLE 1STATUS OF DRAFT GUIDANCE Q&AS AND FINAL GUIDANCE Q&AS
Q&A category
Q&A No.
Previous guidance location
Part I. Biosimilarity or Interchangeability.
Q.I.1
Final
Final.
Q.I.2
Q.I.3
Q.I.4
Q.I.5
Q.I.6
Q.I.7
Q.I.8
Q.I.9
Q.I.10
Q.I.11
Q.I.12
Q.I.13
Q.I.14
Q.I.15
Q.I.16
Q.I.17
Q.I.18
Q.I.19
Q.I.20
Q.I.21
Q.I.22
Q.I.23
Q.I.24
Q.I.25
Q.I.26
Q.I.27
Q.I.28
Q.II.1
Final
Final
Final
Final
Final
Final
Final
Final
Final
Withdrawn
Draft
Final
Final
Final
Draft
Final
Final
Final
Draft
Draft
Draft
Draft
Draft
Draft
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Withdrawn.
Draft.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Withdrawn.
Final.
Draft.
Draft.
Draft.
Draft.
Withdrawn.
Q.II.2
Final
Final.
Part II. Provisions Related to Requirements to Submit a Biologics License Application BLA for a Biological Product.
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Current guidance location
20SEN1
