Current Report Filing (8-k)
July 17 2018 - 4:07PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 17, 2018
COHERUS BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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001-36721
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27-3615821
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification Number)
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333 Twin Dolphin Drive, Suite 600
Redwood City, CA 94065
(Address of principal executive offices, including Zip Code)
Registrants telephone number, including area code: (650)
649-3530
Check the appropriate box below if the Form
8-K
filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company ☐
If an emerging
growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act. ☐
On July 17, 2018, Coherus BioSciences, Inc. (Company)
disclosed that subsequent to the Committee for Medicinal Products for Human Use (CHMP) meeting of June 27
th
, 2018 to consider the pegfilgrastim biosimilar candidate
CHS-1701
application, CHMP identified certain outstanding issues arising from the Day 180 Responses. The Company submitted a full response to these issues on July
3
rd
2018.
The Company has now received the written (co)-Rapporteurs joint assessment
report stating their conclusion that the outstanding issues were satisfactorily addressed and that no further concerns remain with respect to the
CHS-1701
application. The Company understands that the joint
assessment report is now under review by the CHMP.
The Company expects that the
CHS-1701
application will be included on the agenda for the July 2018 CHMP meeting.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on
its behalf by the undersigned hereunto duly authorized.
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Date: July 17, 2018
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COHERUS BIOSCIENCES, INC.
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By:
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/s/ Jean-Frédéric Viret
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Name:
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Jean-Frédéric Viret
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Title:
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Chief Financial Officer
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