80 FR 27321 - Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 92 (May 13, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 92 (May 13, 2015)
| Page Range | 27321-27322 | |
| FR Document | 2015-11528 |
[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)] [Notices] [Pages 27321-27322] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-11528] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0611] Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.'' This draft guidance is intended to provide answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA)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 Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance revises the draft guidance entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,'' issued February 15, 2012, to provide new and revised questions and answers (Q&As). 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 13, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th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 Office of Communication, Outreach and Development (HFM- 40), Center for Biologics Evaluation and Research (CBER), 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. Submit electronic comments on the draft guidance 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. 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 20993-0002, 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 revised draft guidance for industry entitled ``Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.'' This draft guidance provides answers to common questions from sponsors interested in developing proposed biosimilar products, BLA holders, and other interested parties regarding FDA's interpretation of the BPCI Act. This guidance revises the draft guidance entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,'' issued February 15, 2012, to provide new and revised Q&As. It also includes certain original Q&As that have not yet been finalized. The BPCI Act, enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148) on March 23, 2010, created an abbreviated licensure pathway under section 351(k) of the Public Health Service Act (the PHS Act) (42 U.S.C. 262(k)) for biological products demonstrated to be biosimilar to, or interchangeable with, an FDA- licensed reference product. This draft guidance describes FDA's current interpretation of certain statutory requirements added by the BPCI Act and includes Q&As in the following categories:Biosimilarity or Interchangeability Provisions Related to Requirement to Submit a BLA for a ``Biological Product'' [[Page 27322]] Exclusivity The Q&A format is intended to promote transparency and facilitate development programs for proposed biosimilar products by addressing questions that may arise in the early stages of development. In addition, these Q&As respond to questions the Agency has received from prospective BLA and new drug application (NDA) applicants regarding the appropriate statutory authority under which certain products will be regulated. In the Federal Register of February 15, 2012 (77 FR 8885), FDA published a notice announcing the availability of a draft guidance entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.'' Although interested parties can comment on any guidance at any time, to ensure that the Agency considered comments on the draft guidance before beginning work on the final version of the guidance, FDA requested that interested parties submit comments by April 16, 2012. FDA's consideration of these comments, among other things, is reflected in this revised draft guidance (which provides new and revised Q&As) and the final guidance. This revised draft guidance describes the status of the draft guidance Q&As provided in this revised draft guidance and the status of the final guidance Q&As that are included in the guidance entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.'' FDA intends to update these guidances to include additional Q&As as appropriate. 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 this topic. 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. Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov. III. The Paperwork Reduction Act of 1995 This draft guidance refers to information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501- 3520). The submission of an investigational new drug application is covered under 21 CFR part 312 and approved under OMB Control No. 0910- 0014. The submission of an NDA is covered under 21 CFR 314.50 and approved under OMB Control No. 0910-0001. The submission of a BLA under section 351(a) of the PHS Act is covered under part 601 (21 CFR part 601) and approved under OMB Control No. 0910-0338. The submission of a BLA under section 351(k) of the PHS Act is covered under part 601 and approved under OMB control number 0910-0719. IV. Electronic Access Persons with access to the Internet may obtain the document at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov. Dated: May 7, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-11528 Filed 5-12-15; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices 27321
Approved ANDAs that refer to the Dated: May 6, 2015. MD 20993–0002. Send one self-
NDA listed in this document are Leslie Kux, addressed adhesive label to assist that
unaffected by the discontinued Associate Commissioner for Policy. office in processing your requests. See
marketing of the products subject to this [FR Doc. 2015–11526 Filed 5–12–15; 8:45 am] the SUPPLEMENTARY INFORMATION section
NDA. Additional ANDAs that refer to BILLING CODE 4164–01–P
for electronic access to the draft
these products may also be approved by guidance document.
the Agency if they comply with relevant Submit electronic comments on the
legal and regulatory requirements. If DEPARTMENT OF HEALTH AND draft guidance to http://
FDA determines that labeling for these HUMAN SERVICES www.regulations.gov. Submit written
drug products should be revised to meet comments to the Division of Dockets
current standards, the Agency will Food and Drug Administration Management (HFA–305), Food and Drug
advise ANDA applicants to submit such Administration, 5630 Fishers Lane, Rm.
[Docket No. FDA–2011–D–0611]
labeling. 1061, Rockville, MD 20852.
Dated: May 7, 2015. Biosimilars: Additional Questions and FOR FURTHER INFORMATION CONTACT:
Leslie Kux, Answers Regarding Implementation of Sandra Benton, Center for Drug
Associate Commissioner for Policy. the Biologics Price Competition and Evaluation and Research, Food and
[FR Doc. 2015–11529 Filed 5–12–15; 8:45 am] Innovation Act of 2009; Draft Guidance Drug Administration, 10903 New
for Industry; Availability Hampshire Ave., Bldg. 51, Rm. 6340,
BILLING CODE 4164–01–P
Silver Spring, MD 20993–0002, 301–
AGENCY: Food and Drug Administration, 796–1042, or Stephen Ripley, Center for
HHS. Biologics Evaluation and Research,
DEPARTMENT OF HEALTH AND
ACTION: Notice. Food and Drug Administration, 10903
HUMAN SERVICES
New Hampshire Ave., Bldg. 71, Rm.
SUMMARY: The Food and Drug 7301, Silver Spring, MD 20993–0002,
Food and Drug Administration
Administration (FDA or Agency) is 240–402–7911.
announcing the availability of a revised
[Docket No. FDA–2008–N–0312] SUPPLEMENTARY INFORMATION:
draft guidance for industry entitled
‘‘Biosimilars: Additional Questions and I. Background
Agency Information Collection Answers Regarding Implementation of
Activities; Announcement of Office of FDA is announcing the availability of
the Biologics Price Competition and a revised draft guidance for industry
Management and Budget Approval; Innovation Act of 2009.’’ This draft
Extra Label Drug Use in Animals entitled ‘‘Biosimilars: Additional
guidance is intended to provide answers Questions and Answers Regarding
AGENCY: Food and Drug Administration, to common questions from sponsors Implementation of the Biologics Price
HHS. interested in developing proposed Competition and Innovation Act of
biosimilar products, biologics license 2009.’’ This draft guidance provides
ACTION: Notice. application (BLA) holders, and other answers to common questions from
interested parties regarding FDA’s sponsors interested in developing
SUMMARY: The Food and Drug
interpretation of the Biologics Price proposed biosimilar products, BLA
Administration (FDA) is announcing
Competition and Innovation Act of 2009 holders, and other interested parties
that a collection of information entitled,
(BPCI Act). This guidance revises the regarding FDA’s interpretation of the
‘‘Extra Label Drug Use in Animals’’ has
draft guidance entitled ‘‘Biosimilars: BPCI Act. This guidance revises the
been approved by the Office of
Questions and Answers Regarding draft guidance entitled ‘‘Biosimilars:
Management and Budget (OMB) under
Implementation of the Biologics Price Questions and Answers Regarding
the Paperwork Reduction Act of 1995.
Competition and Innovation Act of Implementation of the Biologics Price
FOR FURTHER INFORMATION CONTACT: FDA 2009,’’ issued February 15, 2012, to
PRA Staff, Office of Operations, Food Competition and Innovation Act of
provide new and revised questions and 2009,’’ issued February 15, 2012, to
and Drug Administration, 8455 answers (Q&As).
Colesville Rd., COLE–14526, Silver provide new and revised Q&As. It also
DATES: Although you can comment on includes certain original Q&As that have
Spring, MD 20993–0002, PRAStaff@ any guidance at any time (see 21 CFR
fda.hhs.gov. not yet been finalized.
10.115(g)(5)), to ensure that the Agency The BPCI Act, enacted as part of the
SUPPLEMENTARY INFORMATION: On considers your comment on this draft Patient Protection and Affordable Care
February 18, 2015, the Agency guidance before it begins work on the Act (Pub. L. 111–148) on March 23,
submitted a proposed collection of final version of the guidance, submit 2010, created an abbreviated licensure
information entitled, ‘‘Extra Label Drug either electronic or written comments pathway under section 351(k) of the
Use in Animals’’ to OMB for review and on the draft guidance by July 13, 2015. Public Health Service Act (the PHS Act)
clearance under 44 U.S.C. 3507. An ADDRESSES: Submit written requests for (42 U.S.C. 262(k)) for biological
Agency may not conduct or sponsor, single copies of the draft guidance to the products demonstrated to be biosimilar
and a person is not required to respond Division of Drug Information, Center for to, or interchangeable with, an FDA-
to, a collection of information unless it Drug Evaluation and Research, Food licensed reference product. This draft
displays a currently valid OMB control and Drug Administration, 10001 New guidance describes FDA’s current
asabaliauskas on DSK5VPTVN1PROD with NOTICES
number. OMB has now approved the Hampshire Ave., Hillandale Building, interpretation of certain statutory
information collection and has assigned 4th Floor, Silver Spring, MD 20993– requirements added by the BPCI Act
OMB control number 0910–0325. The 0002, or Office of Communication, and includes Q&As in the following
approval expires on March 31, 2018. A Outreach and Development (HFM–40), categories:
copy of the supporting statement for this Center for Biologics Evaluation and • Biosimilarity or Interchangeability
information collection is available on Research (CBER), Food and Drug • Provisions Related to Requirement
the Internet at http://www.reginfo.gov/ Administration, 10903 New Hampshire to Submit a BLA for a ‘‘Biological
public/do/PRAMain. Ave., Bldg. 71, Rm. 3128, Silver Spring, Product’’
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![27322 Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices
• Exclusivity will be posted to the docket at http:// entitled ‘‘Studies to Evaluate the Safety
The Q&A format is intended to promote www.regulations.gov. of Residues of Veterinary Drugs in
transparency and facilitate development Human Food: Genotoxicity Testing’’
III. The Paperwork Reduction Act of
programs for proposed biosimilar (VICH GL23(R)). This revised guidance
1995
products by addressing questions that has been developed for veterinary use
may arise in the early stages of This draft guidance refers to by the International Cooperation on
development. In addition, these Q&As information collection provisions that Harmonisation of Technical
respond to questions the Agency has are subject to review by the Office of Requirements for Registration of
received from prospective BLA and new Management and Budget (OMB) under Veterinary Medicinal Products (VICH).
drug application (NDA) applicants the Paperwork Reduction Act of 1995 In this VICH guidance, the
regarding the appropriate statutory (the PRA) (44 U.S.C. 3501–3520). The recommendation for a second test to
authority under which certain products submission of an investigational new evaluate the potential of a chemical to
will be regulated. drug application is covered under 21 produce chromosomal effects is revised.
CFR part 312 and approved under OMB The revised guidance indicates that the
In the Federal Register of February
Control No. 0910–0014. The submission potential of a chemical to produce
15, 2012 (77 FR 8885), FDA published
of an NDA is covered under 21 CFR chromosomal effects can be evaluated
a notice announcing the availability of
314.50 and approved under OMB using one of the following three tests:
a draft guidance entitled ‘‘Biosimilars:
Control No. 0910–0001. The submission (1) An in vitro chromosomal aberrations
Questions and Answers Regarding
of a BLA under section 351(a) of the test using metaphase analysis, which
Implementation of the Biologics Price
PHS Act is covered under part 601 (21 detects both clastogenicity and
Competition and Innovation Act of
CFR part 601) and approved under OMB aneugenicity; (2) an in vitro mammalian
2009.’’ Although interested parties can
Control No. 0910–0338. The submission cell micronucleus test, which detects
comment on any guidance at any time,
of a BLA under section 351(k) of the the activity of clastogenicity and
to ensure that the Agency considered
PHS Act is covered under part 601 and aneugenicity; or (3) a mouse lymphoma
comments on the draft guidance before
approved under OMB control number test, which, with modification, can
beginning work on the final version of
0910–0719. detect both gene mutation and
the guidance, FDA requested that
interested parties submit comments by IV. Electronic Access chromosomal damage. This revised
April 16, 2012. FDA’s consideration of VICH guidance document is intended to
Persons with access to the Internet facilitate the mutual acceptance of
these comments, among other things, is may obtain the document at http://
reflected in this revised draft guidance safety data necessary for the
www.fda.gov/Drugs/Guidance establishment of acceptable daily
(which provides new and revised Q&As) ComplianceRegulatoryInformation/
and the final guidance. This revised intakes for veterinary drug residues in
Guidances/default.htm, http:// human food by the relevant regulatory
draft guidance describes the status of www.fda.gov/BiologicsBloodVaccines/
the draft guidance Q&As provided in authorities.
GuidanceComplianceRegulatory
this revised draft guidance and the DATES: Submit either electronic or
Information/default.htm, or http://www.
status of the final guidance Q&As that written comments on Agency guidance
regulations.gov.
are included in the guidance entitled at any time.
‘‘Biosimilars: Questions and Answers Dated: May 7, 2015. ADDRESSES: Submit written requests for
Regarding Implementation of the Leslie Kux, single copies of the revised guidance to
Biologics Price Competition and Associate Commissioner for Policy. the Policy and Regulations Staff (HFV–
Innovation Act of 2009.’’ FDA intends to [FR Doc. 2015–11528 Filed 5–12–15; 8:45 am] 6), Center for Veterinary Medicine, Food
update these guidances to include BILLING CODE 4164–01–P and Drug Administration, 7519 Standish
additional Q&As as appropriate. Pl., Rockville, MD 20855. Send one self-
This draft guidance is being issued addressed adhesive label to assist that
consistent with FDA’s good guidance DEPARTMENT OF HEALTH AND office in processing your request. See
practices regulation (21 CFR 10.115). HUMAN SERVICES the SUPPLEMENTARY INFORMATION section
The draft guidance, when finalized, will for electronic access to the revised
Food and Drug Administration guidance document.
represent the current thinking of FDA
on this topic. It does not establish any [Docket No. FDA–2000–D–0598 (Formerly Submit electronic comments on the
rights for any person and is not binding 2000D–1631)] revised guidance to http://
on FDA or the public. You can use an www.regulations.gov. Submit written
alternative approach if it satisfies the International Cooperation on comments to the Division of Dockets
requirements of the applicable statutes Harmonisation of Technical Management (HFA–305), Food and Drug
and regulations. Requirements for Registration of Administration, 5630 Fishers Lane, Rm.
Veterinary Medicinal Products (VICH 1061, Rockville, MD 20852.
II. Comments GL23(R)); Studies To Evaluate the FOR FURTHER INFORMATION CONTACT:
Interested persons may submit either Safety of Residues of Veterinary Drugs Tong Zhou, Center for Veterinary
electronic comments regarding this in Human Food: Genotoxicity Testing; Medicine (HFV–153), Food and Drug
document to http://www.regulations.gov Revised Guidance for Industry; Administration, 7500 Standish Place,
or written comments to the Division of Availability Rockville, MD 20855, 240–402–0826,
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Dockets Management (see ADDRESSES). It AGENCY: Food and Drug Administration, Tong.Zhou@fda.hhs.gov.
is only necessary to send one set of HHS. SUPPLEMENTARY INFORMATION:
comments. Identify comments with the ACTION: Notice.
docket number found in brackets in the I. Background
heading of this document. Received SUMMARY: The Food and Drug In recent years, many important
comments may be seen in the Division Administration (FDA or Agency) is initiatives have been undertaken by
of Dockets Management between 9 a.m. announcing the availability of a revised regulatory authorities and industry
and 4 p.m., Monday through Friday, and guidance for industry (GFI) #116 associations to promote the
VerDate Sep<11>2014 17:27 May 12, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\13MYN1.SGM 13MYN1](https://thefederalregister.org/doc/80_FR_27413/page/2.svg)
Document Created: 2015-12-16 07:47:06
Document Modified: 2015-12-16 07:47:06
| 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. | |
| 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 July 13, 2015. | |
| Contact | Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 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. | |
| FR Citation | 80 FR 27321 |
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