83 FR 46173 - Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 177 (September 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 177 (September 12, 2018)
| Page Range | 46173-46174 | |
| FR Document | 2018-19811 |
[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)] [Notices] [Pages 46173-46174] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19811] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4853] Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register. FOR FURTHER INFORMATION CONTACT: Angela Hoague, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver Spring, MD 20993-0002, 301- 348-3915, angela.hoague@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was enacted as part of the Patient Protection and Affordable Care Act (Pub. L. 111-148) on March 23, 2010. The BPCI Act amended the PHS Act and created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference [[Page 46174]] product. Section 351(k) of the PHS Act (42 U.S.C. 262(k)), added by the BPCI Act, describes the requirements for a BLA for a proposed biosimilar product or a proposed interchangeable product (351(k) BLA). Section 351(l) of the PHS Act, also added by the BPCI Act, describes certain procedures for exchanging patent information and resolving patent disputes between a 351(k) BLA applicant and the holder of the BLA reference product. If a 351(k) applicant is served with a complaint for a patent infringement described in section 351(l)(6) of the PHS Act, the applicant is required to provide the FDA with notice and a copy of the complaint within 30 days of service. FDA is required to publish notice of a complaint received under section 351(l)(6)(C) of the PHS Act in the Federal Register. FDA received notice of the following complaint under section 351(l)(6)(C) of the PHS Act: Genentech, Inc. and City of Hope v. Amgen Inc., 1:18-cv-00924-GMS (D. Del., filed July 2, 2018). FDA has only a ministerial role in publishing notice of a complaint received under section 351(l)(6)(C) of the PHS Act, and does not perform a substantive review of the complaint. Dated: September 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19811 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices 46173
If you do not wish your name and chemotherapy, as single-agent at least 7 days in advance of the
contact information be made publicly maintenance therapy; and (3) non- meeting.
available, you can provide this progressing (including stable disease), FDA is committed to the orderly
information on the cover sheet and not low-grade, CD20-positive, B-cell NHL as conduct of its advisory committee
in the body of your comments and you a single agent after first-line meetings. Please visit our website at
must identify the information as cyclophosphamide, vincristine, and https://www.fda.gov/Advisory
‘‘confidential.’’ Any information marked prednisone. Committees/AboutAdvisoryCommittees/
as ‘‘confidential’’ will not be disclosed FDA intends to make background ucm111462.htm for procedures on
except in accordance with 21 CFR 10.20 material available to the public no later public conduct during advisory
and other applicable disclosure law. For than 2 business days before the meeting. committee meetings.
more information about FDA’s posting If FDA is unable to post the background Notice of this meeting is given under
of comments to public dockets, see 80 material on its website prior to the the Federal Advisory Committee Act (5
FR 56469, September 18, 2015, or access meeting, the background material will U.S.C. app. 2).
the information at: https://www.gpo.gov/ be made publicly available at the Dated: September 6, 2018.
fdsys/pkg/FR-2015-09-18/pdf/2015- location of the advisory committee Leslie Kux,
23389.pdf. meeting, and the background material Associate Commissioner for Policy.
Docket: For access to the docket to will be posted on FDA’s website after
[FR Doc. 2018–19741 Filed 9–11–18; 8:45 am]
read background documents or the the meeting. Background material is
BILLING CODE 4164–01–P
electronic and written/paper comments available at https://www.fda.gov/
received, go to https:// AdvisoryCommittees/Calendar/
www.regulations.gov and insert the default.htm. Scroll down to the DEPARTMENT OF HEALTH AND
docket number, found in brackets in the appropriate advisory committee meeting HUMAN SERVICES
heading of this document, into the link.
‘‘Search’’ box and follow the prompts Procedure: Interested persons may Food and Drug Administration
and/or go to the Dockets Management present data, information, or views,
Staff, 5630 Fishers Lane, Rm. 1061, [Docket No. FDA–2017–N–4853]
orally or in writing, on issues pending
Rockville, MD 20852. before the committee. All electronic and Receipt of Notice That a Patent
FOR FURTHER INFORMATION CONTACT: written submissions submitted to the Infringement Complaint Was Filed
Lauren D. Tesh, Center for Drug Docket (see ADDRESSES) on or before Against a Biosimilar Applicant
Evaluation and Research, Food and October 1, 2018, will be provided to the
Drug Administration, 10903 New committee. Oral presentations from the AGENCY: Food and Drug Administration,
Hampshire Ave., Bldg. 31, Rm. 2417, public will be scheduled between HHS.
Silver Spring, MD 20993–0002, 301– approximately 11 a.m. and 12 noon. ACTION: Notice.
796–9001, Fax: 301–847–8533, email: Those individuals interested in making
ODAC@fda.hhs.gov; or FDA Advisory formal oral presentations should notify SUMMARY: The Food and Drug
Committee Information Line, 1–800– the contact person and submit a brief Administration (FDA) is publishing
741–8138 (301–443–0572 in the statement of the general nature of the notice that an applicant for a proposed
Washington, DC area). A notice in the evidence or arguments they wish to biosimilar product notified FDA that a
Federal Register about last minute present, the names and addresses of patent infringement action was filed in
modifications that impact a previously proposed participants, and an connection with the applicant’s
announced advisory committee meeting indication of the approximate time biologics license application (BLA).
cannot always be published quickly requested to make their presentation on Under the Public Health Service Act
enough to provide timely notice. or before September 24, 2018. Time (PHS Act), an applicant for a proposed
Therefore, you should always check the allotted for each presentation may be biosimilar product or interchangeable
FDA’s website at https://www.fda.gov/ limited. If the number of registrants product must notify FDA within 30 days
AdvisoryCommittees/default.htm and requesting to speak is greater than can after the applicant was served with a
scroll down to the appropriate advisory be reasonably accommodated during the complaint in a patent infringement
committee meeting link, or call the scheduled open public hearing session, action described under the PHS Act.
advisory committee information line to FDA may conduct a lottery to determine FDA is required to publish notice of the
learn about possible modifications the speakers for the scheduled open complaint in the Federal Register.
before coming to the meeting. public hearing session. The contact FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION: person will notify interested persons Angela Hoague, Center for Drug
Agenda: The committee will discuss regarding their request to speak by Evaluation and Research, Food and
biologics license application 761088 for September 25, 2018. Drug Administration, 10903 New
CT–P10, a proposed biosimilar to Persons attending FDA’s advisory Hampshire Ave., Bldg. 51, Rm. 6257,
Genentech, Inc.’s RITUXAN (rituximab), committee meetings are advised that Silver Spring, MD 20993–0002, 301–
submitted by Celltrion, Inc. The FDA is not responsible for providing 348–3915, angela.hoague@fda.hhs.gov.
proposed indications (uses) for this access to electrical outlets. SUPPLEMENTARY INFORMATION: The
product are for the treatment of adult For press inquiries, please contact the Biologics Price Competition and
patients with (1) relapsed or refractory, Office of Media Affairs at fdaoma@ Innovation Act of 2009 (BPCI Act) was
low-grade or follicular, CD20-positive, fda.hhs.gov or 301–796–4540. enacted as part of the Patient Protection
daltland on DSKBBV9HB2PROD with NOTICES
B-cell Non-Hodgkin’s Lymphoma (NHL) FDA welcomes the attendance of the and Affordable Care Act (Pub. L. 111–
as a single agent; (2) previously public at its advisory committee 148) on March 23, 2010. The BPCI Act
untreated follicular, CD20-positive, B- meetings and will make every effort to amended the PHS Act and created an
cell NHL in combination with first-line accommodate persons with disabilities. abbreviated licensure pathway for
chemotherapy and, in patients If you require accommodations due to a biological products shown to be
achieving a complete or partial response disability, please contact Lauren D. Tesh biosimilar to, or interchangeable with,
to CT–P10 in combination with (see FOR FURTHER INFORMATION CONTACT) an FDA-licensed biological reference
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![46174 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices
product. Section 351(k) of the PHS Act to allow 60 days for public comment in well as any attachments, except for
(42 U.S.C. 262(k)), added by the BPCI response to the notice. This notice information submitted, marked and
Act, describes the requirements for a solicits comments on ‘‘Guidance on identified, as confidential, if submitted
BLA for a proposed biosimilar product Meetings with Industry and as detailed in ‘‘Instructions.’’
or a proposed interchangeable product Investigators on the Research and Instructions: All submissions received
(351(k) BLA). Section 351(l) of the PHS Development of Tobacco Products.’’ must include the Docket No. FDA–
Act, also added by the BPCI Act, DATES: Submit either electronic or 2012–D–0429 for ‘‘Guidance on
describes certain procedures for written comments on the collection of Meetings with Industry and
exchanging patent information and information by November 13, 2018. Investigators on the Research and
resolving patent disputes between a ADDRESSES: You may submit comments
Development of Tobacco Products.’’
351(k) BLA applicant and the holder of as follows. Please note that late, Received comments, those filed in a
the BLA reference product. If a 351(k) untimely filed comments will not be timely manner (see ADDRESSES), will be
applicant is served with a complaint for considered. Electronic comments must placed in the docket and, except for
a patent infringement described in be submitted on or before November 13, those submitted as ‘‘Confidential
section 351(l)(6) of the PHS Act, the 2018. The https://www.regulations.gov Submissions,’’ publicly viewable at
applicant is required to provide the FDA electronic filing system will accept https://www.regulations.gov or at the
with notice and a copy of the complaint comments until midnight Eastern Time Dockets Management Staff between 9
within 30 days of service. FDA is at the end of November 13, 2018. a.m. and 4 p.m., Monday through
required to publish notice of a Comments received by mail/hand Friday.
complaint received under section delivery/courier (for written/paper • Confidential Submissions—To
351(l)(6)(C) of the PHS Act in the submissions) will be considered timely submit a comment with confidential
Federal Register. if they are postmarked or the delivery information that you do not wish to be
FDA received notice of the following service acceptance receipt is on or made publicly available, submit your
complaint under section 351(l)(6)(C) of before that date. comments only as a written/paper
the PHS Act: Genentech, Inc. and City submission. You should submit two
of Hope v. Amgen Inc., 1:18–cv–00924– Electronic Submissions copies total. One copy will include the
GMS (D. Del., filed July 2, 2018). Submit electronic comments in the information you claim to be confidential
FDA has only a ministerial role in following way: with a heading or cover note that states
publishing notice of a complaint • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
received under section 351(l)(6)(C) of https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
the PHS Act, and does not perform a instructions for submitting comments. Agency will review this copy, including
substantive review of the complaint. Comments submitted electronically, the claimed confidential information, in
Dated: September 6, 2018. including attachments, to https:// its consideration of comments. The
Leslie Kux, www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
Associate Commissioner for Policy.
comment will be made public, you are redacted/blacked out, will be available
[FR Doc. 2018–19811 Filed 9–11–18; 8:45 am]
solely responsible for ensuring that your for public viewing and posted on
BILLING CODE 4164–01–P https://www.regulations.gov. Submit
comment does not include any
confidential information that you or a both copies to the Dockets Management
third party may not wish to be posted, Staff. If you do not wish your name and
DEPARTMENT OF HEALTH AND
such as medical information, your or contact information to be made publicly
HUMAN SERVICES
anyone else’s Social Security number, or available, you can provide this
Food and Drug Administration confidential business information, such information on the cover sheet and not
as a manufacturing process. Please note in the body of your comments and you
[Docket No. FDA–2012–D–0429] must identify this information as
that if you include your name, contact
information, or other information that ‘‘confidential.’’ Any information marked
Agency Information Collection as ‘‘confidential’’ will not be disclosed
Activities; Proposed Collection; identifies you in the body of your
comments, that information will be except in accordance with 21 CFR 10.20
Comment Request; Guidance on and other applicable disclosure law. For
Meetings With Industry and posted on https://www.regulations.gov.
• If you want to submit a comment more information about FDA’s posting
Investigators on the Research and of comments to public dockets, see 80
Development of Tobacco Products with confidential information that you
do not wish to be made available to the FR 56469, September 18, 2015, or access
AGENCY: Food and Drug Administration, public, submit the comment as a the information at: https://www.gpo.gov/
HHS. written/paper submission and in the fdsys/pkg/FR-2015-09-18/pdf/2015-
manner detailed (see ‘‘Written/Paper 23389.pdf.
ACTION: Notice.
Submissions’’ and ‘‘Instructions’’). Docket: For access to the docket to
SUMMARY: The Food and Drug read background documents or the
Administration (FDA or Agency) is Written/Paper Submissions electronic and written/paper comments
announcing an opportunity for public Submit written/paper submissions as received, go to https://
comment on the proposed collection of follows: www.regulations.gov and insert the
certain information by the Agency. • Mail/Hand delivery/Courier (for docket number, found in brackets in the
daltland on DSKBBV9HB2PROD with NOTICES
Under the Paperwork Reduction Act of written/paper submissions): Dockets heading of this document, into the
1995 (PRA), Federal Agencies are Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
required to publish notice in the Drug Administration, 5630 Fishers and/or go to the Dockets Management
Federal Register concerning each Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
proposed collection of information, • For written/paper comments Rockville, MD 20852.
including each proposed extension of an submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
existing collection of information, and Staff, FDA will post your comment, as Amber Sanford, Office of Operations,
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Document Created: 2018-09-12 02:06:16
Document Modified: 2018-09-12 02:06:16
| 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. | |
| Contact | Angela Hoague, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver Spring, MD 20993-0002, 301- 348-3915, [email protected] | |
| FR Citation | 83 FR 46173 |
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