Draft Guidances Relating to the Development of Biosimilar Products; Public Hearing; Request for Comments, 12853-12855 [2012-5070]
Download as PDF
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Notices
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
III. 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This draft guidance refers to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 of 1995
(44 U.S.C. 3501–3520) and have been
approved under OMB Control Numbers
0910–0014 and 0910–0001.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: February 28, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–5069 Filed 3–1–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0618]
Draft Guidances Relating to the
Development of Biosimilar Products;
Public Hearing; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public hearing; request
for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
1-day public hearing to obtain input on
recently issued draft guidances relating
to the development of biosimilar
products (draft guidances). These draft
guidances were issued by FDA as part
of the implementation of the Biologics
Price Competition and Innovation Act of
2009 (the BPCI Act). The BPCI Act
establishes an abbreviated licensure
pathway for biological products that are
demonstrated to be biosimilar to, or
interchangeable with, a reference
product. FDA will consider the
information it obtains from the public
hearing in the finalization of these
guidances. In addition, FDA is soliciting
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:01 Mar 01, 2012
Jkt 226001
public input regarding topics for future
policies regarding biosimilars.
DATES: The public hearing will be held
on May 11, 2012, from 8:30 a.m. to 5
p.m. Individuals who wish to present at
the public hearing must register by
April 11, 2012. Section V of this
document provides attendance and
registration information. Electronic or
written comments will be accepted after
the public hearing until May 1, 2012.
ADDRESSES: The public hearing will be
held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503, Silver Spring, MD 20993.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the corresponding
docket number found in brackets in the
heading of this document.
Transcripts of the public hearing will
be available for review at the Division
of Dockets Management and on the
Internet at https://www.regulations.gov
approximately 30 days after the public
hearing (see section VIII of this
document).
A live Web cast of this public hearing
may be seen at https://www.fda.gov/
Drugs/NewsEvents/ucm265628.htm on
the day of the public hearing. A video
record of the public hearing will be
available at the same Web address for
1 year.
FOR FURTHER INFORMATION CONTACT:
Sandra J. 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, Fax: 301–847–3529, email:
biosimilarspublicmtg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On March 23, 2010, President Obama
signed into law the Patient Protection
and Affordable Care Act (Affordable
Care Act) (Pub. L. 111–148). The
Affordable Care Act contains the BPCI
Act that amends the Public Health
Service Act (the PHS Act) and other
statutes to create an abbreviated
licensure pathway for biological
products shown to be biosimilar to, or
interchangeable with, a reference
product (see sections 7001 through 7003
of the Affordable Care Act).
The implementation of an abbreviated
licensure pathway for biological
products can present challenges given
the scientific and technical complexities
that may be associated with the larger
and often more complex structure of
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
12853
biological products, as well as the
processes by which such products are
manufactured. Most biological products
are produced in a living system such as
a microorganism, or plant or animal
cells, whereas small molecule drugs are
typically manufactured through
chemical synthesis.
Among other things, 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 biological product.
Section 351(k) defines biosimilarity to
mean ‘‘that the biological product is
highly similar to the reference product
notwithstanding minor differences in
clinically inactive components’’ and
that ‘‘there are no clinically meaningful
differences between the biological
product and the reference product in
terms of the safety, purity, and potency
of the product.’’ A 351(k) biosimilar
application must contain, among other
things, information demonstrating that
the biological product is biosimilar to a
reference product based upon data
derived from analytical studies, animal
studies and a clinical study or studies,
unless FDA determines that an element
described here is unnecessary in a
351(k) application.
II. Previous Public Hearing on
Biosimilar Pathway
As part of our commitment to public
outreach, FDA held a 2-day public
hearing on the ‘‘Approval Pathway for
Biosimilar and Interchangeable
Biological Products’’ on November 2
and 3, 2010 (75 FR 61497, October 5,
2010) (November 2010 public hearing).
The purpose of that public hearing was
to seek comments on a number of issues
relating to the implementation of the
BPCI Act. Over 40 speakers presented at
the public hearing. In addition to the
presentations, FDA has received more
than 60 public comments to the docket,
which closed on December 31, 2010.
Information on this prior public hearing,
including the Federal Register notice,
meeting transcripts, and public
comments can be found at https://
www.regulations.gov (Docket No. FDA–
2010–N–0477). FDA carefully
considered the presentations and public
comments as it was developing the
recently issued draft guidances (see
section III of this document).
III. Draft Guidances
FDA has issued the following three
draft guidances as part of its initial
implementation of the BPCI Act based
on public input at the November 2010
public hearing regarding priorities for
issuing guidances:
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12854
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
• Scientific Considerations in
Demonstrating Biosimilarity to a
Reference Product (scientific
considerations draft guidance),
• Questions and Answers Regarding
Implementation of the Biologics Price
Competition and Innovation Act of 2009
(Q&A draft guidance), and
• Quality Considerations in
Demonstrating Biosimilarity to a
Reference Protein Product (quality
considerations draft guidance).
The three draft guidances were
published in the Federal Register on
February 15, 2012. The scientific
considerations draft guidance discusses
important scientific considerations in
demonstrating biosimilarity, including
the totality-of-the-evidence approach
FDA will apply to the review of 351(k)
applications and general scientific
principles in conducting comparative
analyses and studies intended to
support a demonstration of
biosimilarity.
The Q&A draft guidance provides
answers to common questions from
sponsors interested in developing
proposed biosimilar products, biologics
license application (BLA) holders, and
other interested parties regarding FDA’s
interpretation of the BPCI Act.
The quality considerations draft
guidance provides recommendations on
general principles and specific factors to
consider when conducting analytical
studies as part of the biosimilarity
assessment.
IV. Purpose and Scope of the Public
Hearing
The purpose of this public hearing is
twofold. First, we wish to receive
comments on these three draft
guidances from a broad group of
stakeholders, such as health care
professionals, health care institutions,
manufacturers of biomedical products,
interested industry and professional
associations, patients and patient
associations, third party payers, current
and prospective BLA and new drug
application (NDA) holders, and the
public. FDA is seeking feedback, both
general and specific, on the scientific
considerations, Q&A, and quality
considerations draft guidances. For
example, FDA would like to know
whether the scope of guidance on a
particular topic satisfactorily addresses
the particular question, whether there
are issues FDA could or should have
addressed and did not, and whether
FDA’s thinking on each topic is
sufficiently clear to provide meaningful
guidance to stakeholders. In addition,
FDA welcomes any comments that will
help us enhance the usefulness and
clarity of these documents.
VerDate Mar<15>2010
17:01 Mar 01, 2012
Jkt 226001
Second, FDA is interested in
obtaining public input regarding the
Agency’s priorities for development of
future policies regarding biosimilars.
One of the questions FDA asked at the
November 2010 public hearing included
what types of guidance documents for
industry should be a priority for the
Agency during the early period of
implementation. In reviewing the
comments received, we noted that many
comments suggested the Agency begin
with general, overarching guidances
describing the general requirements and
principles for biosimilar product
development. We agree with this
approach and have begun with the three
draft guidance documents to be
discussed at this public hearing.
The Agency is interested in soliciting
public input on the Agency’s plans for
development of future policies
regarding biosimilars and whether or
not it aligns with stakeholder needs.
The Agency is also interested in
additional topics that should be
considered. Topics currently under
consideration for future guidances
include the following:
• 351(k) applications seeking a
determination of interchangeability,
• Requests for reference product
exclusivity,
• Naming issues,
• Clinical pharmacology evaluation of
biosimilar products, and
• Q&As Regarding Implementation of
BPCI Act (next set of questions and
answers).1
The Agency is committed to
continued public outreach as we move
forward in our implementation of the
BPCI Act. This notice is part of fulfilling
that ongoing commitment.
V. Attendance and Registration
The FDA Conference Center at the
White Oak location is a Federal facility
with security procedures and limited
seating. Attendance is free and will be
on a first-come, first-served basis.
Individuals who wish to present at the
public hearing must register by sending
an email to
biosimilarspublicmtg@fda.hhs.gov on or
before April 11, 2012, and provide
complete contact information, including
name, title, affiliation, address, email,
and phone number. Those without
email access may register by contacting
Sandra Benton (see FOR FURTHER
INFORMATION CONTACT). You should
identify each guidance you wish to
comment on in your presentation, so
that FDA can consider that in organizing
the presentations. Individuals and
1 The Agency is not bound by this list of possible
topics for future guidances.
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
organizations with common interests
should consolidate or coordinate their
presentations and request time for a
joint presentation. FDA will do its best
to accommodate requests to speak and
will determine the amount of time
allotted for each oral presentation, and
the approximate time that each oral
presentation is scheduled to begin. FDA
will notify registered presenters of their
scheduled times, and make available an
agenda at https://www.fda.gov/Drugs/
NewsEvents/ucm265628.htm
approximately 2 weeks prior to the
public hearing. Once FDA notifies
registered presenters of their scheduled
times, presenters should submit an
electronic copy of their presentation to
biosimilarspublicmtg@fda.hhs.gov by
May 1, 2012.
If you need special accommodations
because of a disability, please contact
Sandra Benton (see FOR FURTHER
INFORMATION CONTACT) at least 7 days
before the meeting.
A live Web cast of this public hearing
may be seen at https://www.fda.gov/
Drugs/NewsEvents/ucm265628.htm on
the day of the public hearing. A video
record of the public hearing will be
available at the same Web address for 1
year.
VI. Notice of Hearing Under 21 CFR
Part 15
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with part 15
(21 CFR part 15). The hearing will be
conducted by a presiding officer, who
will be accompanied by FDA senior
management from the Office of the
Commissioner, the Center for Biologics
Evaluation and Research, and the Center
for Drug Evaluation and Research.
Under § 15.30(f), the hearing is
informal and the rules of evidence do
not apply. No participant may interrupt
the presentation of another participant.
Only the presiding officer and panel
members may question any person
during or at the conclusion of each
presentation. Public hearings under part
15 are subject to FDA’s policy and
procedures for electronic media
coverage of FDA’s public administrative
proceedings (part 10 (21 CFR part 10,
subpart C)). Under § 10.205,
representatives of the electronic media
may be permitted, subject to certain
limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants. The
hearing will be transcribed as stipulated
in § 15.30(b) (see section VIII of this
document). To the extent that the
conditions for the hearing, as described
in this notice, conflict with any
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Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Notices
provisions set out in part 15, this notice
acts as a waiver of those provisions as
specified in § 15.30(h).
VII. Request for Comments
Regardless of attendance at the public
hearing, interested persons may submit
to the Division of Dockets Management
(see ADDRESSES) either electronic or
written comments regarding this
document. It is only necessary to send
one set of comments. Identify comments
with the docket number found in
brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
VIII. Transcripts
Please be advised that as soon as a
transcript is available, it will be
accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A transcript will also
be available in either hard copy or on
CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (ELEM–
1029), Food and Drug Administration,
12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857.
Dated: February 27, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
tkelley on DSK3SPTVN1PROD with NOTICES
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
17:01 Mar 01, 2012
Jkt 226001
Dated: February 24, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–5017 Filed 3–1–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
[FR Doc. 2012–5070 Filed 3–1–12; 8:45 am]
VerDate Mar<15>2010
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel, ZHD1 DSR–Z 55 1.
Date: March 27, 2012.
Time: 2 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard, Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Peter Zelazowski, Ph.D.,
Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development, NIH, 6100 Executive
Boulevard, Room 5b01, Bethesda, MD 20892–
7510, 301–435–6902,
peter.zelazowski@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel, PKA and PKC
Targeting Mechanisms.
Date: March 14, 2012.
Time: 3 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy Boulevard
Bethesda, MD 20892, (Telephone Conference
Call).
Contact Person: Carol J. Goter-Robinson,
Ph.D., Scientific Review Officer, Review
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12855
Branch, DEA, NIDDK, National Institutes of
Health, Room 748, 6707 Democracy
Boulevard Bethesda, MD 20892–5452, (301)
594–7791,
goterrobinsonc@extra.niddk.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: February 24, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–5019 Filed 3–1–12; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel, HIV Disclosure SEP.
Date: March 29–30, 2012.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue Bethesda, MD 20814.
Contact Person: Michele C. HindiAlexander, Ph.D., Scientific Review Officer,
Division of Scientific Review, Eunice
Kennedy Shriver National Institute of Child
Health and Human Development, NIH, 6100
Executive Blvd., Room 5B01, Bethesda, MD
20892, 301–435–8382,
hindialm@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
E:\FR\FM\02MRN1.SGM
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Agencies
[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Notices]
[Pages 12853-12855]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5070]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0618]
Draft Guidances Relating to the Development of Biosimilar
Products; Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public hearing; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a 1-day
public hearing to obtain input on recently issued draft guidances
relating to the development of biosimilar products (draft guidances).
These draft guidances were issued by FDA as part of the implementation
of the Biologics Price Competition and Innovation Act of 2009 (the BPCI
Act). The BPCI Act establishes an abbreviated licensure pathway for
biological products that are demonstrated to be biosimilar to, or
interchangeable with, a reference product. FDA will consider the
information it obtains from the public hearing in the finalization of
these guidances. In addition, FDA is soliciting public input regarding
topics for future policies regarding biosimilars.
DATES: The public hearing will be held on May 11, 2012, from 8:30 a.m.
to 5 p.m. Individuals who wish to present at the public hearing must
register by April 11, 2012. Section V of this document provides
attendance and registration information. Electronic or written comments
will be accepted after the public hearing until May 1, 2012.
ADDRESSES: The public hearing will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503, Silver Spring, MD 20993.
Submit electronic comments to https://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. Identify comments with the corresponding docket number found in
brackets in the heading of this document.
Transcripts of the public hearing will be available for review at
the Division of Dockets Management and on the Internet at https://www.regulations.gov approximately 30 days after the public hearing (see
section VIII of this document).
A live Web cast of this public hearing may be seen at https://www.fda.gov/Drugs/NewsEvents/ucm265628.htm on the day of the public
hearing. A video record of the public hearing will be available at the
same Web address for 1 year.
FOR FURTHER INFORMATION CONTACT: Sandra J. 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, Fax: 301-847-3529, email: biosimilarspublicmtg@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On March 23, 2010, President Obama signed into law the Patient
Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-
148). The Affordable Care Act contains the BPCI Act that amends the
Public Health Service Act (the PHS Act) and other statutes to create an
abbreviated licensure pathway for biological products shown to be
biosimilar to, or interchangeable with, a reference product (see
sections 7001 through 7003 of the Affordable Care Act).
The implementation of an abbreviated licensure pathway for
biological products can present challenges given the scientific and
technical complexities that may be associated with the larger and often
more complex structure of biological products, as well as the processes
by which such products are manufactured. Most biological products are
produced in a living system such as a microorganism, or plant or animal
cells, whereas small molecule drugs are typically manufactured through
chemical synthesis.
Among other things, 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 biological product. Section
351(k) defines biosimilarity to mean ``that the biological product is
highly similar to the reference product notwithstanding minor
differences in clinically inactive components'' and that ``there are no
clinically meaningful differences between the biological product and
the reference product in terms of the safety, purity, and potency of
the product.'' A 351(k) biosimilar application must contain, among
other things, information demonstrating that the biological product is
biosimilar to a reference product based upon data derived from
analytical studies, animal studies and a clinical study or studies,
unless FDA determines that an element described here is unnecessary in
a 351(k) application.
II. Previous Public Hearing on Biosimilar Pathway
As part of our commitment to public outreach, FDA held a 2-day
public hearing on the ``Approval Pathway for Biosimilar and
Interchangeable Biological Products'' on November 2 and 3, 2010 (75 FR
61497, October 5, 2010) (November 2010 public hearing). The purpose of
that public hearing was to seek comments on a number of issues relating
to the implementation of the BPCI Act. Over 40 speakers presented at
the public hearing. In addition to the presentations, FDA has received
more than 60 public comments to the docket, which closed on December
31, 2010. Information on this prior public hearing, including the
Federal Register notice, meeting transcripts, and public comments can
be found at https://www.regulations.gov (Docket No. FDA-2010-N-0477).
FDA carefully considered the presentations and public comments as it
was developing the recently issued draft guidances (see section III of
this document).
III. Draft Guidances
FDA has issued the following three draft guidances as part of its
initial implementation of the BPCI Act based on public input at the
November 2010 public hearing regarding priorities for issuing
guidances:
[[Page 12854]]
Scientific Considerations in Demonstrating Biosimilarity
to a Reference Product (scientific considerations draft guidance),
Questions and Answers Regarding Implementation of the
Biologics Price Competition and Innovation Act of 2009 (Q&A draft
guidance), and
Quality Considerations in Demonstrating Biosimilarity to a
Reference Protein Product (quality considerations draft guidance).
The three draft guidances were published in the Federal Register on
February 15, 2012. The scientific considerations draft guidance
discusses important scientific considerations in demonstrating
biosimilarity, including the totality-of-the-evidence approach FDA will
apply to the review of 351(k) applications and general scientific
principles in conducting comparative analyses and studies intended to
support a demonstration of biosimilarity.
The Q&A draft guidance provides answers to common questions from
sponsors interested in developing proposed biosimilar products,
biologics license application (BLA) holders, and other interested
parties regarding FDA's interpretation of the BPCI Act.
The quality considerations draft guidance provides recommendations
on general principles and specific factors to consider when conducting
analytical studies as part of the biosimilarity assessment.
IV. Purpose and Scope of the Public Hearing
The purpose of this public hearing is twofold. First, we wish to
receive comments on these three draft guidances from a broad group of
stakeholders, such as health care professionals, health care
institutions, manufacturers of biomedical products, interested industry
and professional associations, patients and patient associations, third
party payers, current and prospective BLA and new drug application
(NDA) holders, and the public. FDA is seeking feedback, both general
and specific, on the scientific considerations, Q&A, and quality
considerations draft guidances. For example, FDA would like to know
whether the scope of guidance on a particular topic satisfactorily
addresses the particular question, whether there are issues FDA could
or should have addressed and did not, and whether FDA's thinking on
each topic is sufficiently clear to provide meaningful guidance to
stakeholders. In addition, FDA welcomes any comments that will help us
enhance the usefulness and clarity of these documents.
Second, FDA is interested in obtaining public input regarding the
Agency's priorities for development of future policies regarding
biosimilars. One of the questions FDA asked at the November 2010 public
hearing included what types of guidance documents for industry should
be a priority for the Agency during the early period of implementation.
In reviewing the comments received, we noted that many comments
suggested the Agency begin with general, overarching guidances
describing the general requirements and principles for biosimilar
product development. We agree with this approach and have begun with
the three draft guidance documents to be discussed at this public
hearing.
The Agency is interested in soliciting public input on the Agency's
plans for development of future policies regarding biosimilars and
whether or not it aligns with stakeholder needs. The Agency is also
interested in additional topics that should be considered. Topics
currently under consideration for future guidances include the
following:
351(k) applications seeking a determination of
interchangeability,
Requests for reference product exclusivity,
Naming issues,
Clinical pharmacology evaluation of biosimilar products,
and
Q&As Regarding Implementation of BPCI Act (next set of
questions and answers).\1\
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\1\ The Agency is not bound by this list of possible topics for
future guidances.
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The Agency is committed to continued public outreach as we move
forward in our implementation of the BPCI Act. This notice is part of
fulfilling that ongoing commitment.
V. Attendance and Registration
The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance is
free and will be on a first-come, first-served basis. Individuals who
wish to present at the public hearing must register by sending an email
to biosimilarspublicmtg@fda.hhs.gov on or before April 11, 2012, and
provide complete contact information, including name, title,
affiliation, address, email, and phone number. Those without email
access may register by contacting Sandra Benton (see FOR FURTHER
INFORMATION CONTACT). You should identify each guidance you wish to
comment on in your presentation, so that FDA can consider that in
organizing the presentations. Individuals and organizations with common
interests should consolidate or coordinate their presentations and
request time for a joint presentation. FDA will do its best to
accommodate requests to speak and will determine the amount of time
allotted for each oral presentation, and the approximate time that each
oral presentation is scheduled to begin. FDA will notify registered
presenters of their scheduled times, and make available an agenda at
https://www.fda.gov/Drugs/NewsEvents/ucm265628.htm approximately 2 weeks
prior to the public hearing. Once FDA notifies registered presenters of
their scheduled times, presenters should submit an electronic copy of
their presentation to biosimilarspublicmtg@fda.hhs.gov by May 1, 2012.
If you need special accommodations because of a disability, please
contact Sandra Benton (see FOR FURTHER INFORMATION CONTACT) at least 7
days before the meeting.
A live Web cast of this public hearing may be seen at https://www.fda.gov/Drugs/NewsEvents/ucm265628.htm on the day of the public
hearing. A video record of the public hearing will be available at the
same Web address for 1 year.
VI. Notice of Hearing Under 21 CFR Part 15
The Commissioner of Food and Drugs is announcing that the public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from the Office of the
Commissioner, the Center for Biologics Evaluation and Research, and the
Center for Drug Evaluation and Research.
Under Sec. 15.30(f), the hearing is informal and the rules of
evidence do not apply. No participant may interrupt the presentation of
another participant. Only the presiding officer and panel members may
question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and
procedures for electronic media coverage of FDA's public administrative
proceedings (part 10 (21 CFR part 10, subpart C)). Under Sec. 10.205,
representatives of the electronic media may be permitted, subject to
certain limitations, to videotape, film, or otherwise record FDA's
public administrative proceedings, including presentations by
participants. The hearing will be transcribed as stipulated in Sec.
15.30(b) (see section VIII of this document). To the extent that the
conditions for the hearing, as described in this notice, conflict with
any
[[Page 12855]]
provisions set out in part 15, this notice acts as a waiver of those
provisions as specified in Sec. 15.30(h).
VII. Request for Comments
Regardless of attendance at the public hearing, interested persons
may submit to the Division of Dockets Management (see ADDRESSES) either
electronic or written comments regarding this document. It is only
necessary to send one set of comments. Identify comments with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
VIII. Transcripts
Please be advised that as soon as a transcript is available, it
will be accessible at https://www.regulations.gov. It may be viewed at
the Division of Dockets Management (see ADDRESSES). A transcript will
also be available in either hard copy or on CD-ROM, after submission of
a Freedom of Information request. Written requests are to be sent to
the Division of Freedom of Information (ELEM-1029), Food and Drug
Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
Dated: February 27, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5070 Filed 3-1-12; 8:45 am]
BILLING CODE 4160-01-P