[Federal Register Volume 77, Number 42 (Friday, March 2, 2012)]
[Notices]
[Pages 12853-12855]
From the Federal Register Online via the Government Publishing 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 http://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 http://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 http://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: [email protected].

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 http://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\
---------------------------------------------------------------------------

    \1\ The Agency is not bound by this list of possible topics for 
future guidances.
---------------------------------------------------------------------------

    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 [email protected] 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 
http://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 [email protected] 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 http://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 http://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