83 FR 63898 - New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Revision 2); Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 238 (December 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 238 (December 12, 2018)
| Page Range | 63898-63900 | |
| FR Document | 2018-26852 |
[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)] [Notices] [Pages 63898-63900] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26852] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0611] New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Revision 2); Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).'' 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 This draft guidance document revises the draft guidance document entitled ``Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,'' issued May 13, 2015, to provide new and revised Q&As. DATES: Submit either electronic or written comments on the draft guidance by February 11, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2011-D-0611 for ``New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2); Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For [[Page 63899]] more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: 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. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).'' The 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 BPCI Act. The BPCI Act amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act (42 U.S.C. 262(k)) 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)). 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. FDA intends to update this guidance to include additional Q&As as appropriate. This draft guidance is a companion to the final guidance entitled ``Questions and Answers on Biosimilar Development and the BPCI Act.'' In this pair of guidance documents, FDA issues each Q&A in draft form in this draft guidance, receives comments on the draft Q&A, and, as appropriate, moves the Q&A to the final guidance, after reviewing comments and incorporating suggested changes to the Q&A, when appropriate. Thus, this draft guidance contains Q&As distributed for comment purposes only and includes new Q&As, as well as revisions to Q&As that appeared in previous versions of the draft or final guidance documents. The final guidance contains Q&As that have been through the public comment process and reflects FDA's current thinking on the topics described. 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 another FDA guidance document. FDA has maintained the original numbering of the Q&As used in the April 2015 final guidance (``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009'') and the May 2015 draft guidance (``Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009''). Table 1--Status of Draft Guidance Q&As and Final Guidance Q&As ---------------------------------------------------------------------------------------------------------------- Previous guidance Current guidance Q&A category Q&A Nos. location location ---------------------------------------------------------------------------------------------------------------- Part I. Biosimilarity or Q.I.1................... Final................... Final. Interchangeability. Q.I.2................... Final................... Final. Q.I.3................... Final................... Final. Q.I.4................... Final................... Final. Q.I.5................... Final................... Final. Q.I.6................... Final................... Final. Q.I.7................... Final................... Final. Q.I.8................... Final................... Final. Q.I.9................... Draft................... Final. Q.I.10.................. Draft................... Final. Q.I.11.................. Final................... Withdrawn. Q.I.12.................. Final................... Draft. Q.I.13.................. Draft................... Final. Q.I.14.................. Draft................... Final. Q.I.15.................. Final................... Final. Q.I.16.................. Draft................... Draft. Q.I.17.................. Draft................... Final. Q.I.18.................. Draft................... Final. Q.I.19.................. Draft................... Final. Q.I.20.................. Draft. Q.I.21.................. Draft. Q.I.22.................. Draft. Q.I.23.................. Draft. Q.I.24.................. Draft. [[Page 63900]] Part II. Provisions Related to Q.II.1.................. Final................... Draft. Requirements to Submit a Biologics License Application (BLA) for a ``Biological Product''. Q.II.2.................. Final................... Final. Q.II.3.................. Draft................... Final. Part III. Exclusivity............. Q.III.1................. Draft................... Final. Q.III.2................. Final................... Final. ---------------------------------------------------------------------------------------------------------------- This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The Q&As in this draft guidance, when finalized, will appear in the final guidance, and the final guidance will represent the current thinking of FDA on the Q&As posed in the ``New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).'' It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. FDA is announcing, in a separate document published elsewhere in this issue of the Federal Register, the availability of the guidance for industry entitled ``Questions and Answers on Biosimilar Development and the BPCI Act.'' II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 312 for submission of an investigational new drug application have been approved under OMB control number 0910-0014. The collections of information in 21 CFR 314.50 for submission of a new drug application have been approved under OMB control number 0910-0001. The collections of information in section 351(a) of the PHS Act and part 601 (21 CFR part 601) for submission of a BLA have been approved under OMB control number 0910- 0338. The collections of information in section 351(k) of the PHS Act and part 601 for submission of a BLA have been approved under OMB control number 0910-0719. The collections of information for submission of a meeting package to the appropriate review division with the meeting request as described in the draft guidance for industry ``Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products'' have been approved under OMB control number 0910-0802. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: December 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26852 Filed 12-11-18; 8:45 am] BILLING CODE 4164-01-P
![63898 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
establish any rights for any person and DEPARTMENT OF HEALTH AND identifies you in the body of your
is not binding on FDA or the public. HUMAN SERVICES comments, that information will be
You can use an alternative approach if posted on https://www.regulations.gov.
it satisfies the requirements of the Food and Drug Administration • If you want to submit a comment
applicable statutes and regulations. This [Docket No. FDA–2011–D–0611]
with confidential information that you
guidance is not subject to Executive do not wish to be made available to the
Order 12866. New and Revised Draft Q&As on public, submit the comment as a
Biosimilar Development and the written/paper submission and in the
II. Paperwork Reduction Act of 1995 Biologics Price Competition and manner detailed (see ‘‘Written/Paper
Innovation Act (Revision 2); Draft Submissions’’ and ‘‘Instructions’’).
This guidance refers to previously
Guidance for Industry; Availability Written/Paper Submissions
approved collections of information
found in FDA regulations. These AGENCY: Food and Drug Administration, Submit written/paper submissions as
collections of information are subject to HHS. follows:
review by the Office of Management and ACTION: Notice of availability. • Mail/Hand delivery/Courier (for
Budget (OMB) under the Paperwork written/paper submissions): Dockets
SUMMARY: The Food and Drug Management Staff (HFA–305), Food and
Reduction Act of 1995 (44 U.S.C. 3501–
Administration (FDA or Agency) is Drug Administration, 5630 Fishers
3520). The collection of information in
announcing the availability of a draft Lane, Rm. 1061, Rockville, MD 20852.
21 CFR part 312 has been approved guidance for industry entitled ‘‘New and • For written/paper comments
under OMB control number 0910–0014; Revised Draft Q&As on Biosimilar submitted to the Dockets Management
the collection of information in 21 CFR Development and the BPCI Act Staff, FDA will post your comment, as
part 314 has been approved under OMB (Revision 2).’’ The question and answer well as any attachments, except for
control number 0910–0001; the (Q&A) format is intended to inform information submitted, marked and
collection of information in 21 CFR part prospective applicants and facilitate the identified, as confidential, if submitted
601 has been approved under OMB development of proposed biosimilars as detailed in ‘‘Instructions.’’
control number 0910–0338; and the and proposed interchangeable Instructions: All submissions received
collection of information for biosimilars, as well as to describe FDA’s must include the Docket No. FDA–
applications submitted under section interpretation of certain statutory 2011–D–0611 for ‘‘New and Revised
351(k) of the PHS Act has been requirements added by the Biologics Draft Q&As on Biosimilar Development
approved under OMB control number Price Competition and Innovation Act of and the BPCI Act (Revision 2); Draft
0910–0719; the collection of 2009 (BPCI Act). This draft guidance Guidance for Industry.’’ Received
information in FDA’s guidance for document revises the draft guidance comments will be placed in the docket
industry entitled ‘‘Formal Meetings document entitled ‘‘Biosimilars: and, except for those submitted as
Between the FDA and Biosimilar Additional Questions and Answers ‘‘Confidential Submissions,’’ publicly
Biological Product Sponsors or Regarding Implementation of the viewable at https://www.regulations.gov
Applicants’’ has been approved under Biologics Price Competition and or at the Dockets Management Staff
OMB control number 0910–0802; and Innovation Act of 2009,’’ issued May 13, between 9 a.m. and 4 p.m., Monday
the collection of information in FDA’s 2015, to provide new and revised Q&As. through Friday.
DATES: Submit either electronic or • Confidential Submissions—To
guidance for industry entitled ‘‘Formal
written comments on the draft guidance submit a comment with confidential
Meetings Between the FDA and
by February 11, 2019 to ensure that the information that you do not wish to be
Sponsors or Applicants of PDUFA made publicly available, submit your
Products’’ has been approved under Agency considers your comment on this
draft guidance before it begins work on comments only as a written/paper
OMB control number 0910–0429. submission. You should submit two
the final version of the guidance.
III. Electronic Access ADDRESSES: You may submit comments copies total. One copy will include the
on any guidance at any time as follows: information you claim to be confidential
Persons with access to the internet with a heading or cover note that states
may obtain the guidance at either Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
https://www.fda.gov/Drugs/Guidance Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
ComplianceRegulatoryInformation/ following way: Agency will review this copy, including
Guidances/default.htm, https:// • Federal eRulemaking Portal: the claimed confidential information, in
www.fda.gov/BiologicsBloodVaccines/ https://www.regulations.gov. Follow the its consideration of comments. The
GuidanceComplianceRegulatory instructions for submitting comments. second copy, which will have the
Information/Guidances/default.htm, or Comments submitted electronically, claimed confidential information
https://www.regulations.gov. including attachments, to https:// redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on
Dated: December 6, 2018. the docket unchanged. Because your https://www.regulations.gov. Submit
Leslie Kux, comment will be made public, you are both copies to the Dockets Management
Associate Commissioner for Policy. solely responsible for ensuring that your Staff. If you do not wish your name and
[FR Doc. 2018–26854 Filed 12–11–18; 8:45 am] comment does not include any contact information to be made publicly
confidential information that you or a available, you can provide this
amozie on DSK3GDR082PROD with NOTICES1
BILLING CODE 4164–01–P
third party may not wish to be posted, information on the cover sheet and not
such as medical information, your or in the body of your comments and you
anyone else’s Social Security number, or must identify this information as
confidential business information, such ‘‘confidential.’’ Any information marked
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed
that if you include your name, contact except in accordance with 21 CFR 10.20
information, or other information that and other applicable disclosure law. For
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![63900 Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
TABLE 1—STATUS OF DRAFT GUIDANCE Q&AS AND FINAL GUIDANCE Q&AS—Continued
Previous Current
Q&A category Q&A Nos. guidance guidance
location location
Part II. Provisions Related to Requirements to Submit a Biologics License Application (BLA) Q.II.1 .............. Final ............... Draft.
for a ‘‘Biological Product’’.
Q.II.2 .............. Final ............... Final.
Q.II.3 .............. Draft ............... Final.
Part III. Exclusivity ...................................................................................................................... Q.III.1 ............. Draft ............... Final.
Q.III.2 ............. Final ............... Final.
This draft guidance is being issued described in the draft guidance for Implementation of the Biologics Price
consistent with FDA’s good guidance industry ‘‘Formal Meetings Between the Competition and Innovation Act of
practices regulation (21 CFR 10.115). FDA and Sponsors or Applicants of 2009’’ issued April 28, 2015.
The Q&As in this draft guidance, when BsUFA Products’’ have been approved DATES: The announcement of the
finalized, will appear in the final under OMB control number 0910–0802. guidance is published in the Federal
guidance, and the final guidance will Register on December 12, 2018.
III. Electronic Access
represent the current thinking of FDA ADDRESSES: You may submit either
on the Q&As posed in the ‘‘New and Persons with access to the internet
electronic or written comments on
Revised Draft Q&As on Biosimilar may obtain the draft guidance at either
Agency guidances at any time as
Development and the BPCI Act https://www.fda.gov/Drugs/Guidance
follows:
(Revision 2).’’ It does not establish any ComplianceRegulatoryInformation/
rights for any person and is not binding Guidances/default.htm or https:// Electronic Submissions
on FDA or the public. You can use an www.regulations.gov. Submit electronic comments in the
alternative approach if it satisfies the Dated: December 6, 2018. following way:
requirements of the applicable statutes Leslie Kux, • Federal eRulemaking Portal:
and regulations. This guidance is not Associate Commissioner for Policy. https://www.regulations.gov. Follow the
subject to Executive Order 12866. instructions for submitting comments.
[FR Doc. 2018–26852 Filed 12–11–18; 8:45 am]
FDA is announcing, in a separate Comments submitted electronically,
BILLING CODE 4164–01–P
document published elsewhere in this including attachments, to https://
issue of the Federal Register, the www.regulations.gov will be posted to
availability of the guidance for industry DEPARTMENT OF HEALTH AND the docket unchanged. Because your
entitled ‘‘Questions and Answers on HUMAN SERVICES comment will be made public, you are
Biosimilar Development and the BPCI solely responsible for ensuring that your
Act.’’ Food and Drug Administration comment does not include any
II. Paperwork Reduction Act of 1995 confidential information that you or a
[Docket No. FDA–2011–D–0611]
third party may not wish to be posted,
This draft guidance refers to such as medical information, your or
Biosimilars: Questions and Answers
previously approved collections of anyone else’s Social Security number, or
on Biosimilar Development and the
information found in FDA regulations. confidential business information, such
Biologics Price Competition and
These collections of information are as a manufacturing process. Please note
Innovation Act of 2009; Guidance for
subject to review by the Office of that if you include your name, contact
Industry; Availability
Management and Budget (OMB) under information, or other information that
the Paperwork Reduction Act of 1995 AGENCY: Food and Drug Administration, identifies you in the body of your
(44 U.S.C. 3501–3520). The collections HHS. comments, that information will be
of information in 21 CFR part 312 for ACTION: Notice of availability. posted on https://www.regulations.gov.
submission of an investigational new • If you want to submit a comment
drug application have been approved SUMMARY: The Food and Drug with confidential information that you
under OMB control number 0910–0014. Administration (FDA or Agency) is do not wish to be made available to the
The collections of information in 21 announcing the availability of a final public, submit the comment as a
CFR 314.50 for submission of a new guidance for industry entitled written/paper submission and in the
drug application have been approved ‘‘Questions and Answers on Biosimilar manner detailed (see ‘‘Written/Paper
under OMB control number 0910–0001. Development and the BPCI Act.’’ The Submissions’’ and ‘‘Instructions’’).
The collections of information in question and answer (Q&A) format is
section 351(a) of the PHS Act and part intended to inform prospective Written/Paper Submissions
601 (21 CFR part 601) for submission of applicants and facilitate the Submit written/paper submissions as
a BLA have been approved under OMB development of proposed biosimilars follows:
control number 0910–0338. The and proposed interchangeable • Mail/Hand delivery/Courier (for
collections of information in section biosimilars, as well as to describe FDA’s written/paper submissions): Dockets
amozie on DSK3GDR082PROD with NOTICES1
351(k) of the PHS Act and part 601 for interpretation of certain statutory Management Staff (HFA–305), Food and
submission of a BLA have been requirements added by the Biologics Drug Administration, 5630 Fishers
approved under OMB control number Price Competition and Innovation Act of Lane, Rm. 1061, Rockville, MD 20852.
0910–0719. The collections of 2009 (BPCI Act). This guidance • For written/paper comments
information for submission of a meeting document revises the final guidance submitted to the Dockets Management
package to the appropriate review document entitled ‘‘Biosimilars: Staff, FDA will post your comment, as
division with the meeting request as Questions and Answers Regarding well as any attachments, except for
VerDate Sep<11>2014 18:39 Dec 11, 2018 Jkt 247001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\12DEN1.SGM 12DEN1](https://thefederalregister.org/doc/83_FR_64136/page/3.svg)
Document Created: 2018-12-12 01:40:01
Document Modified: 2018-12-12 01:40:01
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on the draft guidance by February 11, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | 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. | |
| FR Citation | 83 FR 63898 |
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