[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Proposed Rules]
[Pages 12966-12969]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06438]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 15
[Docket No. FDA-2019-N-1132]
The Future of Insulin Biosimilars: Increasing Access and
Facilitating the Efficient Development of Biosimilar and
Interchangeable Insulin Products; Public Hearing; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of public hearing; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing a public hearing to discuss access to affordable insulin
products and issues related to the development and approval of
biosimilar and interchangeable insulin products.
DATES: The public hearing will be held on May 13, 2019, from 9 a.m. to
5 p.m. The public hearing may be extended or may end early depending on
the level of public participation. Persons seeking to present at the
public hearing must register by April 29, 2019. Persons seeking to
speak at the public hearing must register by May 9, 2019. Persons
seeking to attend, but not present at, the public hearing must register
by May 9, 2019. Section III provides attendance and registration
information. Electronic or written comments will be accepted after the
public hearing until May 31, 2019.
ADDRESSES: The public hearing will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503B), Silver Spring, MD 20993-0002. Entrance for public hearing
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before May 31, 2019. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of May 31, 2019. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
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-2019-N-1132 for ``The Future of Insulin Biosimilars: Increasing
Access and Facilitating the Efficient Development of Insulin Biosimilar
and Interchangeable Products; Public Hearing; Request for Comments.''
Received comments, those filed in a timely manner (see
[[Page 12967]]
ADDRESSES), 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.
FOR FURTHER INFORMATION CONTACT: Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3138, Silver
Spring, MD 20993, 301-796-9203, [email protected] (please use
``Insulin Biosimilars part 15'' as subject line).
SUPPLEMENTARY INFORMATION:
I. Background
The Biologics Price Competition and Innovation Act of 2009 (BPCI
Act) requires that on March 23, 2020, an approved marketing application
for a biological product under section 505 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355) will be deemed to be a
license for the biological product under section 351 of the Public
Health Service Act (PHS Act) (42 U.S.C. 262) and regulated under the
PHS Act. The transition of biological products currently approved under
the FD&C Act to the PHS Act will open the pathway to market for new
products that are biosimilar to, or interchangeable with, these
transitioned products. The biological products affected by this
transition include insulin products, insulin mix products, and insulin
analog products (collectively described in this notification as
``insulin products''), which historically have been approved under the
FD&C Act.
Insulin is a lifesaving drug that many Americans depend on to treat
their diabetes. In recent years, however, increases in the prices of
insulin products have raised serious concerns about the ability for
many patients to access the insulin needed to survive. FDA is holding
this public hearing to receive input from stakeholders as the Agency
prepares for the submission and review of applications for biosimilar
and interchangeable insulin products. FDA anticipates that these
products, once they are approved, will bring new competition to the
insulin market and help provide affordable treatment options to
patients with diabetes without compromising safety and effectiveness.
The BPCI Act amended the PHS Act and other statutes to create an
abbreviated licensure pathway for biological products shown to be
biosimilar to, or interchangeable with, an FDA-licensed biological
reference product. This abbreviated pathway allows an applicant to rely
on certain existing knowledge about the safety and effectiveness of a
biological reference product to support approval, provided the sponsor
can demonstrate that its product meets the applicable statutory
standards, including biosimilarity. Thus, the sponsor may be able to
develop the biosimilar at a lower cost, relative to the development of
a novel biological product submitted in a stand-alone marketing
application. The PHS Act 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'' (section 351(i)(2) of the PHS
Act).
An interchangeable biosimilar may be substituted for the reference
product without the intervention of the prescribing healthcare provider
(see section 351(i)(3) of the PHS Act). To meet the standard of
``interchangeability,'' an applicant must provide sufficient
information to demonstrate: (1) Biosimilarity; (2) that the biological
product can be expected to produce the same clinical result as the
reference product in any given patient; and (3) for products
administered more than once to an individual, that the risk in terms of
safety or diminished efficacy of alternating or switching between the
use of the biological product and the reference product is not greater
than the risk of using the reference product without such alternation
or switch (section 351(k)(4) of the PHS Act).
After the March 23, 2020, transition, insulin products that will be
deemed to be licensed under the PHS Act will be able to act as
reference products for proposed biosimilar or interchangeable insulin
products. There are currently no approved prescription insulin products
that can be substituted at the pharmacy level. An interchangeable
insulin product can be substituted for the reference insulin product at
the pharmacy, potentially leading to increased access and lower costs
for patients.
This public hearing is a component of FDA's broader effort to
facilitate the growth of a competitive market for biologics. In July
2018, FDA issued its Biosimilars Action Plan, which focuses on four
areas of FDA activities: (1) Improving the efficiency of the biosimilar
and interchangeable product development and approval process; (2)
maximizing scientific and regulatory clarity for the biosimilar product
development community; (3) developing effective communications to
improve understanding of biosimilars among patients, clinicians, and
payors; and (4) supporting market competition by reducing gaming of FDA
requirements or other attempts to unfairly delay competition. On
September 4, 2018, FDA held a public meeting entitled ``Facilitating
Competition and Innovation in the Biological Products Marketplace''
(see 83 FR 35154, July 25, 2018) and received submissions to an
associated docket (Docket No. FDA-2018-N-2689).
II. Purpose and Scope of the Public Hearing
FDA is holding this public hearing to receive input from patients,
families,
[[Page 12968]]
healthcare providers, and other stakeholders who live with diabetes or
care for someone with diabetes about the challenges and opportunities
FDA should consider as we prepare for the submission and review of
applications for biosimilar and interchangeable insulin products. We
also want to hear from manufacturers and other stakeholders about the
development process for biosimilar and interchangeable insulin
products. FDA has determined that a public hearing is the most
appropriate way to ensure public engagement on these topics.
Questions for Commenters to Address: FDA is soliciting input on
steps the Agency can take to facilitate increased access to insulin
products, including biosimilar and interchangeable insulin products.
FDA is interested in how we can encourage the development of biosimilar
and interchangeable insulin products, while achieving the balance
between competition and innovation intended by Congress in the BPCI
Act. Although FDA welcomes all feedback on any public health,
scientific, regulatory, or legal considerations relating to this topic,
we particularly encourage commenters to consider the following topics
and questions as they prepare their comments or statements.
1. Scientific standards for evaluating the biosimilarity and
interchangeability of an insulin product.
a. What considerations should FDA take into account when evaluating
data and other information submitted by an applicant, including from
analytical and clinical studies, to determine whether an insulin
product is biosimilar to a reference product?
b. What considerations should FDA take into account when evaluating
data and other information submitted by an applicant, to determine
whether an insulin product is interchangeable with a reference product?
2. Other regulatory considerations: Do certain insulin products,
for example, those that include use in insulin pumps for continuous
subcutaneous infusion among the approved uses or those approved with
over-the-counter marketing status, raise unique scientific
considerations? What factors should FDA consider when evaluating a
proposed biosimilar or interchangeable insulin product if the reference
product raises such considerations? Are there additional factors FDA
should evaluate for interchangeable insulin products, which may be
substituted at the pharmacy for the reference product without the
involvement of the prescriber?
3. Patient experience: What aspects of the patient experience with
insulin products should FDA consider when evaluating a proposed
biosimilar or interchangeable insulin product?
4. Information resources for patients, clinicians, pharmacists, and
other stakeholders: What information is needed to develop effective
communications to improve understanding and promote awareness among
patients, clinicians, pharmacists, and other stakeholders about
biosimilar and interchangeable insulin products?
III. Participating in the Public Hearing
The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance will
be free and on a first-come, first-served basis. An agenda for the
hearing and any other background materials will be made available 5
days before the hearing at https://www.fda.gov/FDAgov/NewsEvents/MeetingsConferencesWorkshops/ucm632081.htm. If you need special
accommodations because of a disability, please contact Allison Hoffman
(see FOR FURTHER INFORMATION CONTACT) at least 7 days before the
hearing.
Registration and Requests for Formal Oral Presentations: For those
interested in presenting at the meeting with a formal oral
presentation, please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``In-person presenter''.
Presenter registrations are due April 29, 2019.
FDA will try to accommodate all persons who wish to make a formal
oral presentation. Formal oral presenters may use an accompanying slide
deck. Individuals wishing to present should identify their name,
affiliation (if appropriate), and the number of the specific question,
or questions, they wish to address. This will help FDA organize the
presentations. Individuals and organizations with common interests
should consider consolidating or coordinating their presentations and
request time for a joint presentation. Individual organizations are
limited to a single presentation slot. FDA will notify registered
presenters of their scheduled presentation times. The time allotted for
each presentation will depend on the number of individuals who wish to
speak. Registered presenters making a formal oral presentation are
encouraged to submit an electronic copy of their presentation
(PowerPoint or PDF) to [email protected] with the subject line
``Insulin Biosimilars part 15 Presentation'' on or before May 6, 2019.
Persons registered to present are encouraged to arrive at the hearing
room early and check in at the onsite registration table to confirm
their designated presentation time. Actual presentation times, however,
may vary based on how the meeting progresses in real time.
Registration and Requests for Open Public Hearing Speaker slots:
For those interested in participating as an Open Public Hearing
speaker, please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``In-person Open Public
Hearing presenter''. Open Public Hearing registrations are due May 9,
2019; however, you may sign up as an Open Public Hearing speaker the
day of the meeting. Time and space are limited and available on a
first-come, first-served basis. Open Public Hearing speakers have less
allotted time than formal oral presenters and will deliver oral
testimony only (no accompanying slide deck).
Persons registered to participate during the Open Public Hearing
are encouraged to arrive at the hearing room early and check in at the
onsite registration table to confirm their Open Public Hearing
participation.
Those without internet or email access can request to participate
as a formal presenter or an open public hearing speaker by contacting
Allison Hoffman by the above dates (see FOR FURTHER INFORMATION
CONTACT).
In-person attendance: For those who would like to attend in-person,
but who are not making a formal presentation or participating in the
Open Public Hearing, please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``In-person
attendee--no participation''. You may choose not to register; however,
seating is limited, and space will be available on a first-come, first-
served basis.
Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live webcast of the hearing. To join the
hearing via the webcast, please go to https://collaboration.fda.gov/insulin051319. Please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``online (webcast only)''.
Media: Please register at https://www.eventbrite.com/e/insulin-biosimilar-part-15-tickets-56571622245 as ``Media'' by May 9, 2019.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.fda.gov/FDAgov/NewsEvents/MeetingsConferencesWorkshops/ucm632081.htm and https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES).
[[Page 12969]]
IV. 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 Devices and Radiological Health, the
Center for Drug Evaluation and Research, and the Office of the Chief
Counsel. Under Sec. 15.30(f) (21 CFR 15.30(f)), the hearing is
informal, and the rules of evidence do not apply. No participant may
interrupt the presentation of another participant. Public hearings
under part 15 are subject to FDA's policy and procedures for electronic
media coverage of FDA's public administrative proceedings (21 CFR part
10, subpart C). Under 21 CFR 10.205, representatives of the media may
be permitted, subject to certain limitations, to videotape, film, or
otherwise record FDA's public administrative proceedings, including
presentations by participants. Persons attending FDA's hearings are
advised that the Agency is not responsible for providing access to
electrical outlets. The hearing will be transcribed as stipulated in
Sec. 15.30(b) (see Transcripts). To the extent that the conditions for
the hearing, as described in this notification, conflict with any
provisions set out in part 15, this notification acts as a waiver of
those provisions as specified in Sec. 15.30(h).
Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06438 Filed 4-2-19; 8:45 am]
BILLING CODE 4164-01-P