제2의 한미약품..셀트리온..미국입성합니다

 

2/9일 FDA자문회의가 열리는데...의제가 렘시마에 승인에 대한 건이라는 것을 알리는 공지입니다.

승인 가능성 99% 이상이고 4월부터 미국 시장이 열릴 것이라고 셀트리온 김형기 사장이 말했습니다.

어제 오늘 공매도가 엄청 나오면서 주가를 끌어내렸는데...월요일 주가는 어떻게 될지 아무도 모릅니다.

동업자인 저의 관심은 렘시마가 얼마나 빨리 미국으로 진입하느냐 였는데...

이렇게 되면 두번째 레미케이드 시밀러와는 2년 이상 선점이 가능하게 되고...(나와도 1~2년 이상 로컬 임상 데이터 쌓아야 함)

휴미라, 엔브렐 시밀러는 특허 때문에 2020년 이후에나 미국에 출시가 가능할 예정이라고 하니

적어도 3~4년 이상 렘시마의 독주가 예상됩니다.

 

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Arthritis Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food
and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Arthritis Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the
Agency on FDA's regulatory issues.
Date and Time: The meeting will be held on February 9, 2016, from 7:30 a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference
Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly
asked questions including information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at:
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
Contact Person: Stephanie L. Begansky, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD
20993-0002, 301- 796-9001, FAX: 301-847-8533, AAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A
notice in the Federal Register about last minute modifications that impact a previously
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announced advisory committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site at
http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee information line to learn about
possible modifications before coming to the meeting.
Agenda: The committee will discuss biologics license application (BLA) 125544, for
CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab), submitted by
Celltrion, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and
symptoms and inducing and maintaining clinical remission in adult patients with moderately to
severely active Crohn's disease who have had an inadequate response to conventional therapy;
(2) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining
fistula closure in adult patients with fistulizing Crohn's disease; (3) reducing signs and symptoms
and inducing and maintaining clinical remission in pediatric patients 6 years of age and older
with moderately to severely active Crohn's disease who have had an inadequate response to
conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical
remission and mucosal healing, and eliminating corticosteroid use in adult patients with
moderately to severely active ulcerative colitis who have had an inadequate response to
conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical
remission in pediatric patients 6 years of age and older with moderately to severely active
ulcerative colitis who have had an inadequate response to conventional therapy;1 (6) in
combination with methotrexate, reducing signs and symptoms, inhibiting the progression of
structural damage, and improving physical function in patients with moderately to severely
1 This indication is protected by orphan drug exclusivity expiring on September 23, 2018. See the Orphan Drug
Designations and Approvals database at http://www.accessdata.fda.gov/scripts/opdlisting/oopd/index.cfm.
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active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing
spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of
structural damage, and improving physical function in patients with psoriatic arthritis; and (9)
treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis
who are candidates for systemic therapy and when other systemic therapies are medically less
appropriate.
FDA intends to make background material available to the public no later than 2 business
days before the meeting. If FDA is unable to post the background material on its Web site prior
to the meeting, the background material will be made publicly available at the location of the
advisory committee meeting, and the background material will be posted on FDA's Web site
after the meeting. Background material is available at
http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate
advisory committee meeting link.
Procedure: Interested persons may present data, information, or views, orally or in
writing, on issues pending before the committee. Written submissions may be made to the
contact person on or before January 26, 2016. Oral presentations from the public will be
scheduled between approximately 1:30 p.m. and 3 p.m. Those individuals interested in making
formal oral presentations should notify the contact person and submit a brief statement of the
general nature of the evidence or arguments they wish to present, the names and addresses of
proposed participants, and an indication of the approximate time requested to make their
presentation on or before January 14, 2016. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a lottery to determine the
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speakers for the scheduled open public hearing session. The contact person will notify interested
persons regarding their request to speak by January 15, 2016.
Persons attending FDA's advisory committee meetings are advised that the Agency is not
responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will
make every effort to accommodate persons with disabilities. If you require accommodations due
to a disability, please contact Stephanie L. Begansky at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please
visit our Web site at
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for
procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.
2).
Dated: January 11, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-823 Filed: 1/15/2016 8:45 am; Publication Date: 1/19/2016]