[Federal Register Volume 84, Number 99 (Wednesday, May 22, 2019)]
[Notices]
[Pages 23569-23571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10667]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-2102]
Development of Therapeutic Protein Biosimilars: Comparative
Analytical Assessment and Other Quality-Related Considerations; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Development of Therapeutic Protein Biosimilars: Comparative
Analytical Assessment and Other Quality-Related Considerations.'' This
draft guidance describes the Agency's recommendations on the design and
evaluation of comparative analytical studies intended to support a
demonstration that a proposed therapeutic protein product is biosimilar
to a reference product licensed under the Public Health Service Act
(PHS Act). Additionally, this draft guidance is intended to provide
recommendations to sponsors on the scientific and technical information
for the chemistry, manufacturing, and controls (CMC) portion of a
marketing application for a proposed product submitted under the PHS
Act. This draft guidance revises the guidance entitled ``Quality
Considerations in Demonstrating Biosimilarity of a Therapeutic Protein
Product to a Reference Product'' that was published on April 30, 2015.
DATES: Submit either electronic or written comments on the draft
guidance by July 22, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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
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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-2019-D-2102 for ``Development of Therapeutic Protein Biosimilars:
Comparative Analytical Assessment and Other Quality-Related
Considerations.'' 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 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.gpo.gov/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 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 to 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 20993-0002, 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 ``Development of Therapeutic Protein Biosimilars: Comparative
Analytical Assessment and Other Quality-Related Considerations.'' This
draft guidance describes the Agency's recommendations on the design and
evaluation of comparative analytical studies intended to support a
demonstration that a proposed therapeutic protein product is biosimilar
to a reference product licensed under section 351(a) of the PHS Act (42
U.S.C. 262(a)). Additionally, this draft guidance is intended to
provide recommendations to sponsors on of the scientific and technical
information for the CMC portion of a marketing application for a
proposed product submitted under section 351(k) of the PHS Act.
Although the 351(k) pathway applies generally to biological products,
this guidance focuses on therapeutic protein products.
The Biologics Price Competition and Innovation Act of 2009 was
enacted as part of the Patient Protection and Affordable Care Act (Pub.
L. 111-148) on March 23, 2010, and created an abbreviated licensure
pathway under section 351(k) of the PHS Act for biological products
demonstrated to be biosimilar to, or interchangeable with, a reference
product. Under this abbreviated licensure pathway, FDA will license a
proposed biological product submitted under section 351(k) of the PHS
Act if, among other things, FDA determines that the information
submitted in the application is sufficient to show that the biological
product is biosimilar to the reference product.
In the Federal Register of February 15, 2012 (77 FR 8884), FDA
announced the availability of the draft guidance entitled ``Quality
Considerations in Demonstrating Biosimilarity to a Reference Protein
Product.'' FDA received a number of comments on the draft guidance. In
response to these comments, FDA provided further clarification on the
general principles described through a final guidance entitled
``Quality Considerations in Demonstrating Biosimilarity of a
Therapeutic Protein Product to a Reference Product,'' which was
announced in the Federal Register of April 30, 2015 (80 FR 24257).
In the Federal Register of September 22, 2017 (82 FR 44425), FDA
announced the availability of the draft guidance entitled ``Statistical
Approaches to Evaluate Analytical Similarity.'' FDA received a number
of comments on the draft guidance. Comments submitted to the docket
addressed a range of issues that could impact the cost and efficiency
of biosimilar development, including the number of reference product
lots the draft guidance would have recommended that biosimilar
developers sample in their evaluation of high similarity and the
statistical methods for this evaluation. After considering the public
comments that FDA received, FDA determined it would withdraw the draft
guidance to give further consideration to the scientific and regulatory
issues involved. FDA announced the withdrawal of the draft
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guidance on June 21, 2018, with the intention of issuing future draft
guidance on the evaluation of analytical data to support a
demonstration that a proposed biosimilar product is highly similar to a
reference product.
This draft guidance revises the guidance issued on April 30, 2015.
FDA has adjusted the title of this draft guidance to more clearly
communicate that this draft guidance includes the Agency's
recommendations on the design and evaluation of comparative analytical
studies intended to support a demonstration that a proposed therapeutic
protein product is biosimilar to a reference product. In addition to
editorial and clarifying edits, the draft guidance includes a section
that fulfills the Biosimilar User Fee Act II commitment to publish a
revised draft or final guidance, describing statistical considerations
for the analysis of analytical similarity data intended to support a
demonstration of ``highly similar'' for biosimilar biological products
within 18 months after the close of the public comment period for the
withdrawn guidance, ``Statistical Approaches to Evaluate Analytical
Similarity.''
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 ``Development
of Therapeutic Protein Biosimilars: Comparative Analytical Assessment
and Other Quality-Related Considerations.'' 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.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations, which are not expected to change
as a result of the guidance. 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 related to the submission of: (1) An
investigational new drug application, which is covered under 21 CFR
part 312 and approved under OMB control number 0910-0014; (2) a new
drug application, which is covered under 21 CFR 314.50 and approved
under OMB control number 0910-0001; (3) a biologics license application
(BLA) under section 351(a) of the PHS Act, which is covered under part
601 (21 CFR part 601) and approved under OMB control number 0910-0338;
and (4) a BLA under section 351(k), which is covered under part 601 and
approved under OMB control number 0910-0719.
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, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: May 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10667 Filed 5-21-19; 8:45 am]
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