82 FR 36149 - 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 82, Issue 148 (August 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 148 (August 3, 2017)
| Page Range | 36149-36150 | |
| FR Document | 2017-16380 |
[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)] [Notices] [Pages 36149-36150] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-16380] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-2489] Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- [[Page 36150]] 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: Daniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993-0002, 240-402-0979, [email protected]. 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 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 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: Amgen, Inc., et al. v. Coherus Biosciences, Inc., 17-cv-00546 (D. Del., filed May 10, 2017). 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: July 31, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-16380 Filed 8-2-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices 36149
Submit written requests for single FDA-regulated drug products that bear the Office of Management and Budget
copies of the draft guidance to the CRP statements, regardless of whether (OMB) under the Paperwork Reduction
Division of Drug Information, Center for CRP is required for such products under Act of 1995 (44 U.S.C. 3501–3520). The
Drug Evaluation and Research, Food 16 CFR 1700. For example, bulk collection of information for submitting
and Drug Administration, 10001 New packages of prescription drugs that are labeling in original and supplemental
Hampshire Ave., Hillandale Building, shipped to pharmacies for repackaging new drug applications (NDAs),
4th Floor, Silver Spring, MD 20993– by a pharmacist are not required to abbreviated new drug applications
0002; or to the Office of utilize CRP, but a firm may nevertheless (ANDAs), and biologics license
Communication, Outreach and choose to use CRP (and a CRP applications (BLAs) in 21 CFR 314.50(e)
Development, Center for Biologics statement) for such drugs. and (l), 314.94(a)(8), 314.70, and 314.97,
Evaluation and Research, Food and CPSC’s regulations list ‘‘special and 21 CFR 601.2 and 601.12 has been
Drug Administration, 10903 New packaging standards’’ (also referred to approved under OMB control number
Hampshire Ave., Bldg. 71, Rm. 3128, herein as child-resistant packaging, or 0910–0001 and 0910–0338, respectively.
Silver Spring, MD 20993–0002. Send CRP) for a wide range of household The collection of information for
one self-addressed adhesive label to products, including most oral preparing prescription drug product
assist that office in processing your prescription drugs and many labeling under 21 CFR 201.56 and
requests. See the SUPPLEMENTARY nonprescription drug products (see 16 201.57 has been approved under OMB
INFORMATION section for electronic CFR 1700 for substances requiring control number 0910–0572. The
access to the draft guidance document. special packaging and the relevant collection of information for Drug Facts
FOR FURTHER INFORMATION CONTACT:
packaging standards and testing labeling under 21 CFR 201.66 has been
Richard Lostritto, Center for Drug procedures). There are different ways to approved under OMB control number
Evaluation and Research, Food and make packaging child-resistant, with the 0910–0340. The collection of
most common forms being a child- information for Medication Guides has
Drug Administration, 10903 New
resistant closure (e.g., a ‘‘safety cap’’) been approved under OMB control
Hampshire Ave., Bldg. 51, Rm. 4132,
and certain unit-dose blister packaging number 0910–0393. The collection of
Silver Spring, MD 20993, 301–796–
(e.g., puncture-resistant and peel-push information for submitting chemistry,
1697; or Stephen Ripley, Center for
blisters). manufacturing, and controls
Biologics Evaluation and Research, Child-resistant packaging is regarded
Food and Drug Administration, 10903 information in original and
as an important public health safety tool supplemental NDAs, ANDAs, and BLAs
New Hampshire Ave., Bldg. 71, Rm. for avoiding harmful outcomes related
7301, Silver Spring, MD 20993–0002, in 21 CFR 314.50(d)(1), 314.94(a)(9),
to unsupervised pediatric ingestions. 314.70, and 314.97, and 21 CFR 601.2
240–402–7911. FDA advocates that all drugs,
SUPPLEMENTARY INFORMATION: and 601.12 has been approved under
irrespective of the type of packaging, be OMB control number 0910–0001 and
I. Background stored safely out of reach and sight of 0910–0338, respectively.
children to further the overall public
FDA is announcing the availability of health efforts to address this safety III. Electronic Access
a draft guidance for industry entitled issue.
‘‘Child-Resistant Packaging Statements Persons with access to the Internet
Because health care professionals and may obtain the draft guidance at either
in Drug Product Labeling.’’ In 1970, the consumers may not be able to determine
Poison Prevention Packaging Act https://www.fda.gov/Drugs/
on visual inspection whether the GuidanceComplianceRegulatory
(PPPA) was enacted to protect children packaging is child-resistant, a labeling
(under 5 years of age) from Information/Guidances/default.htm,
statement may help to identify this https://www.fda.gov/BiologicsBlood
unintentional exposure to household attribute. Therefore, in this guidance,
substances including food, drugs, and Vaccines/GuidanceCompliance
we recommend text that may be RegulatoryInformation/Guidances/
cosmetics. Under the Federal Food, appropriate to consider when including
Drug, and Cosmetic Act (the FD&C Act), default.htm, or https://www.regulations.
CRP statements on the containers and gov.
a drug that has packaging or labeling packaging of products.
that is in violation of a regulation issued This draft guidance is being issued Dated: July 31, 2017.
pursuant to section 3 or 4 of the PPPA consistent with FDA’s good guidance Anna K. Abram,
is deemed to be misbranded. FDA was practices regulation (21 CFR 10.115). Deputy Commissioner for Policy, Planning,
responsible for enforcing the PPPA until The draft guidance, when finalized, will Legislation, and Analysis.
1973, when jurisdiction was transferred represent the current thinking of FDA [FR Doc. 2017–16379 Filed 8–2–17; 8:45 am]
to the U.S. Consumer Product Safety on child-resistant packaging statements BILLING CODE 4164–01–P
Commission (CPSC). Because of FDA’s in drug product labeling. It does not
authority to regulate labeling for establish any rights for any person and
prescription and nonprescription drug is not binding on FDA or the public. DEPARTMENT OF HEALTH AND
products, if firms choose to make You can use an alternative approach if HUMAN SERVICES
statements in their labeling for such it satisfies the requirements of the
products about CRP, such statements applicable statutes and regulations. Food and Drug Administration
must comply with FDA’s statutory and Because FDA’s guidance documents do
regulatory requirements. The draft not bind the public or FDA to any [Docket No. FDA–2015–N–2489]
guidance explains that to ensure that requirements, this guidance is not
mstockstill on DSK30JT082PROD with NOTICES
CRP statements on labeling are not false Receipt of Notice That a Patent
considered to be subject to Executive
or misleading, such statements should Infringement Complaint Was Filed
Order 12866.
only be used when the drug product Against a Biosimilar Applicant
packaging has been shown to comply II. Paperwork Reduction Act of 1995
AGENCY: Food and Drug Administration,
with the applicable CPSC regulatory This draft guidance refers to HHS.
standards and test procedures for CRP. previously approved collections of
ACTION: Notice.
This guidance is intended to apply to information that are subject to review by
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![36150 Federal Register / Vol. 82, No. 148 / Thursday, August 3, 2017 / Notices
SUMMARY: The Food and Drug resolving patent disputes between a ACTION: Notice.
Administration (FDA) is publishing 351(k) BLA applicant and the holder of
notice that an applicant for a proposed the BLA reference product. If a 351(k) SUMMARY: The Food and Drug
biosimilar product notified FDA that a applicant is served with a complaint for Administration (FDA or Agency) is
patent infringement action was filed in a patent infringement described in withdrawing approval of three new drug
connection with the applicant’s section 351(l)(6) of the PHS Act, the applications (NDAs) and one
biologics license application (BLA). applicant is required to provide FDA abbreviated new drug application
Under the Public Health Service Act with notice and a copy of the complaint (ANDA) held by B. Braun Medical, Inc.
(PHS Act), an applicant for a proposed within 30 days of service. FDA is B. Braun Medical, Inc., notified the
biosimilar product or interchangeable required to publish notice of a
Agency in writing that the drug
product must notify FDA within 30 days complaint received under section
351(l)(6)(C) of the PHS Act in the products were no longer marketed and
after the applicant was served with a
Federal Register. requested that the approval of the
complaint in a patent infringement
FDA received notice of the following applications be withdrawn.
action described under the PHS Act.
FDA is required to publish notice of the complaint under section 351(l)(6)(C) of DATES: Effective September 5, 2017.
complaint in the Federal Register. the PHS Act: Amgen, Inc., et al. v.
Coherus Biosciences, Inc., 17–cv–00546 FOR FURTHER INFORMATION CONTACT:
FOR FURTHER INFORMATION CONTACT:
(D. Del., filed May 10, 2017). Valerie A. Butler, Center for Biologics
Daniel Orr, Center for Drug Evaluation FDA has only a ministerial role in Evaluation and Research, Food and
and Research, Food and Drug publishing notice of a complaint Drug Administration, 10903 New
Administration, 10903 New Hampshire received under section 351(l)(6)(C) of Hampshire Ave., Bldg. 71, Rm. 7301,
Ave., Bldg. 51, Rm. 6246, Silver Spring, the PHS Act and does not perform a Silver Spring, MD 20993–0002, 240–
MD 20993–0002, 240–402–0979, substantive review of the complaint.
daniel.orr@fda.hhs.gov. 402–7911.
Dated: July 31, 2017.
SUPPLEMENTARY INFORMATION: The SUPPLEMENTARY INFORMATION: B. Braun
Anna K. Abram, Medical, Inc., 901 Marcon Blvd.,
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) was Deputy Commissioner for Policy, Planning, Allentown, PA 18109, has informed
Legislation, and Analysis.
enacted as part of the Patient Protection FDA that the following three NDAs and
[FR Doc. 2017–16380 Filed 8–2–17; 8:45 am]
and Affordable Care Act (Pub. L. 111– one ANDA are no longer marketed and
148) on March 23, 2010. The BPCI Act BILLING CODE 4164–01–P
has requested that FDA withdraw
amended the PHS Act and created an approval of the applications under the
abbreviated licensure pathway for process in § 314.150(c) (21 CFR
DEPARTMENT OF HEALTH AND
biological products shown to be 314.150(c)). By its request, B. Braun
HUMAN SERVICES
biosimilar to, or interchangeable with, Medical, Inc., has also waived its
an FDA-licensed biological reference Food and Drug Administration opportunity for a hearing. Withdrawal
product. Section 351(k) of the PHS Act of approval of an application under
(42 U.S.C. 262(k)), added by the BPCI [Docket No. FDA–2017–N–0002]
§ 314.150(c) is without prejudice to
Act, describes the requirements for a refiling.
B. Braun Medical, Inc.; Withdrawal of
BLA for a proposed biosimilar product
Approval of Three New Drug
or a proposed interchangeable product
Applications and One Abbreviated New
(351(k) BLA). Section 351(l) of the PHS
Drug Application
Act, also added by the BPCI Act,
describes certain procedures for AGENCY: Food and Drug Administration,
exchanging patent information and HHS.
NDA/ANDA Proprietary name
BN 090024 .................................................... Dextran 70, 6% Dextran 70 in 0.9% NaCl Injection.
BN 160767 .................................................... Dextran 40, 10% Dextran 40 in 0.9% NaCl Injection and 10% Dextran 40 in 5% Dextrose.
BN 890104 .................................................... Pentaspan® (10% Pentastarch in 0.9% NaCl Injection in EXCEL Containers).
BA 740283 ..................................................... Hespan® (6% Hetastarch in 0.9% NaCl in EXCEL Containers).
Therefore, approval of the drug products have reached their DEPARTMENT OF HEALTH AND
applications listed in the table, and all expiration dates or otherwise becomes HUMAN SERVICES
amendments and supplements thereto, violative, whichever occurs first.
is hereby withdrawn, effective Office of the Secretary
Dated: July 31, 2017.
September 5, 2017. Introduction or
Anna K. Abram, Findings of Research Misconduct
delivery for introduction into interstate
commerce for products without an Deputy Commissioner for Policy, Planning,
AGENCY: Office of the Secretary, HHS.
approved NDA or ANDA violates Legislation, and Analysis.
[FR Doc. 2017–16377 Filed 8–2–17; 8:45 am]
ACTION: Notice.
section 301(a) and (d) of the Federal
mstockstill on DSK30JT082PROD with NOTICES
Food, Drug, and Cosmetic Act (21 U.S.C. BILLING CODE 4164–01–P Notice is hereby given that the Office
331(a) and (d)). Drug products that are of Research Integrity (ORI) has taken
listed in the table that are in inventory final action in the following case:
on the date that this notice becomes Nasser Chegini, Ph.D., University of
effective (see the DATES section) may Florida: Based on the report of an
continue to be dispensed until the investigation conducted by the
inventories have been depleted or the University of Florida (UF), the prior
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Document Created: 2017-08-03 07:24:53
Document Modified: 2017-08-03 07:24:53
| 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 | Daniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993-0002, 240-402-0979, [email protected] | |
| FR Citation | 82 FR 36149 |
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