81 FR 19194 - Labeling for Biosimilar Products; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 64 (April 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 64 (April 4, 2016)
| Page Range | 19194-19195 | |
| FR Document | 2016-07611 |
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)] [Notices] [Pages 19194-19195] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07611] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-D-0643] Labeling for Biosimilar Products; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Labeling for Biosimilar Products.'' This draft guidance is intended to assist applicants in developing draft prescription drug labeling for proposed biosimilar products. The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert). This draft guidance provides an overview of FDA's recommendations for labeling for biosimilar products licensed under the Public Health Service Act (PHS Act). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 3, 2016. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2016-D-0643 for ``Labeling for Biosimilar Products; Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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 more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the 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. 51, Rm. 6340, 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 ``Labeling for Biosimilar Products.'' The Biologics Price Competition and Innovation Act of 2009 (BCPI Act), enacted as part of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148) on March 23, 2010, created an abbreviated [[Page 19195]] licensure pathway for biological products demonstrated to be biosimilar to or interchangeable with a reference product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI Act, sets forth the requirements for an application for a proposed biosimilar product and an application or supplement for a proposed interchangeable product. Under section 351(k) of the PHS Act, a proposed biological product that is demonstrated to be biosimilar to a reference product can rely on certain existing scientific knowledge about the safety, purity, and potency of the reference product to support licensure, and this is reflected in the approach to biosimilar product labeling. In this draft guidance, FDA outlines its recommendations for biosimilar product labeling. A demonstration of biosimilarity means, among other things, that FDA has determined that there are no clinically meaningful differences between the proposed product and the reference product in terms of safety, purity and potency. Accordingly, biosimilar applicants should incorporate relevant data and information from the reference product labeling, with appropriate product-specific modifications as described in the draft guidance. We invite comment on the draft guidance, including whether patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use) should include a biosimilarity statement similar to the statement described in section IV.C.1 of the draft guidance. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on labeling for biosimilar products. 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. II. The 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 (PRA) of 1995 (44 U.S.C. 3501-3520). The collections of information under 21 CFR part 601 for the submission of a biologics license application under section 351(k) of the PHS Act have been approved under OMB control number 0910-0719; the collections of information under 21 CFR 201.57 for the submission of labeling have been approved under OMB control number 0910-0572; the collections of information under 21 CFR part 600 for the submission of adverse experience reporting for licensed biological products and general records have been approved under OMB control number 0910-0308; and the collections of information under 21 CFR part 600 for the submission of MedWatch reporting forms (FDA Form 3500 and FDA Form 3500A) have been approved under OMB control number 0910-0291. III. Electronic Access Persons with access to the Internet may obtain the draft guidance at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov. Dated: March 29, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-07611 Filed 4-1-16; 8:45 am] BILLING CODE 4164-01-P
![19194 Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices
IV. Electronic Access confidential information that you or a made publicly available, you can
Persons with access to the Internet third party may not wish to be posted, provide this information on the cover
may obtain the draft guidance at http:// such as medical information, your or sheet and not in the body of your
www.fda.gov/RegulatoryInformation/ anyone else’s Social Security number, or comments and you must identify this
Guidances/, http://www.regulations.gov, confidential business information, such information as ‘‘confidential.’’ Any
or http://www.fda.gov/medicalcounter as a manufacturing process. Please note information marked as ‘‘confidential’’
measures. that if you include your name, contact will not be disclosed except in
information, or other information that accordance with 21 CFR 10.20 and other
Dated: March 29, 2016. identifies you in the body of your applicable disclosure law. For more
Leslie Kux, comments, that information will be information about FDA’s posting of
Associate Commissioner for Policy. posted on http://www.regulations.gov. comments to public dockets, see 80 FR
[FR Doc. 2016–07478 Filed 4–1–16; 8:45 am] • If you want to submit a comment 56469, September 18, 2015, or access
BILLING CODE 4164–01–P with confidential information that you the information at: http://www.fda.gov/
do not wish to be made available to the regulatoryinformation/dockets/
public, submit the comment as a default.htm.
DEPARTMENT OF HEALTH AND written/paper submission and in the Docket: For access to the docket to
HUMAN SERVICES manner detailed (see ‘‘Written/Paper read background documents or the
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
Food and Drug Administration received, go to http://
Written/Paper Submissions
[Docket No. FDA–2016–D–0643] www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
Labeling for Biosimilar Products; Draft follows: heading of this document, into the
Guidance for Industry; Availability • Mail/Hand delivery/Courier (for
‘‘Search’’ box and follow the prompts
written/paper submissions): Division of
AGENCY: Food and Drug Administration, and/or go to the Division of Dockets
Dockets Management (HFA–305), Food
HHS. Management, 5630 Fishers Lane, Rm.
and Drug Administration, 5630 Fishers
1061, Rockville, MD 20852.
ACTION: Notice of availability. Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments Submit written requests for single
SUMMARY: The Food and Drug submitted to the Division of Dockets copies of the draft guidance to the
Administration (FDA or Agency) is Management, FDA will post your Division of Drug Information, Center for
announcing the availability of a draft comment, as well as any attachments, Drug Evaluation and Research, Food
guidance for industry entitled ‘‘Labeling except for information submitted, and Drug Administration, 10001 New
for Biosimilar Products.’’ This draft marked and identified, as confidential, Hampshire Ave., Hillandale Building,
guidance is intended to assist applicants if submitted as detailed in 4th Floor, Silver Spring, MD 20993–
in developing draft prescription drug ‘‘Instructions.’’ 0002, or the Office of Communication,
labeling for proposed biosimilar Instructions: All submissions received Outreach and Development, Center for
products. The recommendations for must include the Docket No. FDA– Biologics Evaluation and Research,
prescription drug labeling in this 2016–D–0643 for ‘‘Labeling for Food and Drug Administration, 10903
guidance pertain only to the prescribing Biosimilar Products; Draft Guidance for New Hampshire Ave., Bldg. 71, Rm.
information (commonly referred to as Industry; Availability.’’ Received 3128, Silver Spring, MD 20993–0002.
the package insert). This draft guidance comments will be placed in the docket Send one self-addressed adhesive label
provides an overview of FDA’s and, except for those submitted as to assist that office in processing your
recommendations for labeling for ‘‘Confidential Submissions,’’ publicly requests. See the SUPPLEMENTARY
biosimilar products licensed under the viewable at http://www.regulations.gov INFORMATION section for electronic
Public Health Service Act (PHS Act). or at the Division of Dockets access to the draft guidance document.
DATES: Although you can comment on Management between 9 a.m. and 4 p.m., FOR FURTHER INFORMATION CONTACT:
any guidance at any time (see 21 CFR Monday through Friday. Sandra Benton, Center for Drug
10.115(g)(5)), to ensure that the Agency • Confidential Submissions—To Evaluation and Research, Food and
considers your comment on this draft submit a comment with confidential Drug Administration, 10903 New
guidance before it begins work on the information that you do not wish to be Hampshire Ave., Bldg. 51, Rm. 6340,
final version of the guidance, submit made publicly available, submit your Silver Spring, MD 20993, 301–796–
either electronic or written comments comments only as a written/paper 1042, or Stephen Ripley, Center for
on the draft guidance by June 3, 2016. submission. You should submit two Biologics Evaluation and Research,
ADDRESSES: You may submit comments copies total. One copy will include the Food and Drug Administration, 10903
as follows: information you claim to be confidential New Hampshire Ave., Bldg. 71, Rm.
with a heading or cover note that states 7301, Silver Spring, MD 20993–0002,
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS 240–402–7911.
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION:
following way: Agency will review this copy, including
• Federal eRulemaking Portal: http:// the claimed confidential information, in I. Background
www.regulations.gov. Follow the its consideration of comments. The FDA is announcing the availability of
mstockstill on DSK4VPTVN1PROD with NOTICES
instructions for submitting comments. second copy, which will have the a draft guidance for industry entitled
Comments submitted electronically, claimed confidential information ‘‘Labeling for Biosimilar Products.’’ The
including attachments, to http:// redacted/blacked out, will be available Biologics Price Competition and
www.regulations.gov will be posted to for public viewing and posted on http:// Innovation Act of 2009 (BCPI Act),
the docket unchanged. Because your www.regulations.gov. Submit both enacted as part of the Patient Protection
comment will be made public, you are copies to the Division of Dockets and Affordable Care Act (Affordable
solely responsible for ensuring that your Management. If you do not wish your Care Act) (Pub. L. 111–148) on March
comment does not include any name and contact information to be 23, 2010, created an abbreviated
VerDate Sep<11>2014 19:03 Apr 01, 2016 Jkt 238001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\04APN1.SGM 04APN1](https://thefederalregister.org/doc/81_FR_19258/page/1.svg)
![Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Notices 19195
licensure pathway for biological approved under OMB control number supplements to these applications. This
products demonstrated to be biosimilar 0910–0719; the collections of guidance also applies to comparability
to or interchangeable with a reference information under 21 CFR 201.57 for the protocols submitted in investigational
product. Section 351(k) of the PHS Act submission of labeling have been new animal drug (INAD), generic
(42 U.S.C. 262(k)), added by the BPCI approved under OMB control number investigational new animal drug
Act, sets forth the requirements for an 0910–0572; the collections of (JINAD), and veterinary master file
application for a proposed biosimilar information under 21 CFR part 600 for (VMF) submissions that are referenced
product and an application or the submission of adverse experience in applications. FDA is providing this
supplement for a proposed reporting for licensed biological guidance in response to requests from
interchangeable product. Under section products and general records have been those interested in using comparability
351(k) of the PHS Act, a proposed approved under OMB control number protocols.
biological product that is demonstrated 0910–0308; and the collections of DATES: Submit either electronic or
to be biosimilar to a reference product information under 21 CFR part 600 for written comments on Agency guidances
can rely on certain existing scientific the submission of MedWatch reporting at any time.
knowledge about the safety, purity, and forms (FDA Form 3500 and FDA Form
ADDRESSES: You may submit comments
potency of the reference product to 3500A) have been approved under OMB
support licensure, and this is reflected control number 0910–0291. as follows:
in the approach to biosimilar product Electronic Submissions
III. Electronic Access
labeling.
In this draft guidance, FDA outlines Persons with access to the Internet Submit electronic comments in the
its recommendations for biosimilar may obtain the draft guidance at http:// following way:
product labeling. A demonstration of www.fda.gov/Drugs/Guidance • Federal eRulemaking Portal: http://
biosimilarity means, among other ComplianceRegulatoryInformation/ www.regulations.gov. Follow the
things, that FDA has determined that Guidances/default.htm, http:// instructions for submitting comments.
there are no clinically meaningful www.fda.gov/BiologicsBloodVaccines/ Comments submitted electronically,
differences between the proposed GuidanceComplianceRegulatory including attachments, to http://
product and the reference product in Information/Guidances/default.htm, or www.regulations.gov will be posted to
terms of safety, purity and potency. http://www.regulations.gov. the docket unchanged. Because your
Accordingly, biosimilar applicants comment will be made public, you are
Dated: March 29, 2016. solely responsible for ensuring that your
should incorporate relevant data and Leslie Kux,
information from the reference product comment does not include any
Associate Commissioner for Policy. confidential information that you or a
labeling, with appropriate product-
specific modifications as described in [FR Doc. 2016–07611 Filed 4–1–16; 8:45 am] third party may not wish to be posted,
the draft guidance. BILLING CODE 4164–01–P such as medical information, your or
We invite comment on the draft anyone else’s Social Security number, or
guidance, including whether patient confidential business information, such
labeling (e.g., Patient Information, DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
Medication Guide, and Instructions for HUMAN SERVICES that if you include your name, contact
Use) should include a biosimilarity information, or other information that
Food and Drug Administration
statement similar to the statement identifies you in the body of your
described in section IV.C.1 of the draft [Docket No. FDA–2016–D–0938 (formerly comments, that information will be
guidance. FDA–2003–D–0034 and 2003D–0061)] posted on http://www.regulations.gov.
This draft guidance is being issued • If you want to submit a comment
Comparability Protocols—Chemistry, with confidential information that you
consistent with FDA’s good guidance
Manufacturing, and Controls do not wish to be made available to the
practices regulation (21 CFR 10.115).
Information for New Animal Drugs; public, submit the comment as a
The draft guidance, when finalized, will
Guidance for Industry; Availability written/paper submission and in the
represent the current thinking of FDA
on labeling for biosimilar products. It AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper
does not establish any rights for any HHS. Submissions’’ and ‘‘Instructions’’).
person and is not binding on FDA or the ACTION: Notice of availability. Written/Paper Submissions
public. You can use an alternative
approach if it satisfies the requirements SUMMARY: The Food and Drug Submit written/paper submissions as
of the applicable statutes and Administration (FDA) is announcing the follows:
regulations. availability of a final guidance for • Mail/Hand delivery/Courier (for
industry (#156) entitled ‘‘Comparability written/paper submissions): Division of
II. The Paperwork Reduction Act of Protocols—Chemistry, Manufacturing, Dockets Management (HFA–305), Food
1995 and Controls Information for New and Drug Administration, 5630 Fishers
This draft guidance refers to Animal Drugs.’’ This document Lane, Rm. 1061, Rockville, MD 20852.
previously approved collections of provides recommendations to • For written/paper comments
information found in FDA regulations. applicants on preparing and using submitted to the Division of Dockets
These collections of information are comparability protocols for Management, FDA will post your
mstockstill on DSK4VPTVN1PROD with NOTICES
subject to review by the Office of postapproval changes in chemistry, comment, as well as any attachments,
Management and Budget (OMB) under manufacturing, and controls (CMC) except for information submitted,
the Paperwork Reduction Act (PRA) of information. It is intended to provide marked and identified, as confidential,
1995 (44 U.S.C. 3501–3520). The recommendations to industry regarding if submitted as detailed in
collections of information under 21 CFR comparability protocols that would be ‘‘Instructions.’’
part 601 for the submission of a submitted in new animal drug Instructions: All submissions received
biologics license application under applications (NADAs), abbreviated new must include the Docket No. FDA–
section 351(k) of the PHS Act have been animal drug applications (ANADAs), or 2016–D–0938 for ‘‘Comparability
VerDate Sep<11>2014 19:03 Apr 01, 2016 Jkt 238001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 E:\FR\FM\04APN1.SGM 04APN1](https://thefederalregister.org/doc/81_FR_19258/page/2.svg)
Document Created: 2016-04-02 03:53:33
Document Modified: 2016-04-02 03:53:33
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by June 3, 2016. | |
| Contact | Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, 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 | 81 FR 19194 |
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