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Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab
First Amgen Biosimilar Candidate and Adalimumab Biosimilar Candidate to be Reviewed by U.S. FDA Advisory Committee
THOUSAND OAKS, Calif., July 12, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee. ABP 501 is a biosimilar candidate to Humira® (adalimumab), an anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, which is approved in many regions for the treatment of several inflammatory diseases.

During the meeting, Amgen will present a comprehensive data package which supports biosimilarity of ABP 501 to adalimumab based on analytical, nonclinical, clinical and pharmacokinetic data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical comparability to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab.

"As a developer of innovative medicines and biosimilars, Amgen has worked diligently to apply our more than 35 years of experience in biotechnology to the development of biosimilars," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Today, we're looking forward to discussing the efficacy, safety and immunogenicity profile of ABP 501, Amgen's first prospective biosimilar, with the FDA advisory committee. If approved, ABP 501 has the potential to provide an additional treatment option for patients with chronic inflammatory diseases, as well as play a key role in long-term disease management."

The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016 for ABP 501.
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Source: press release, 7/12/16. http://wwwext.amgen.com/media/news-releases/2016/07/amgen-to-discuss-dat...

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Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab

THOUSAND OAKS, Calif., June 13, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the Company's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira® (adalimumab).

"With our heritage in both rheumatology and dermatology, we are committed to providing physicians and patients a variety of biologic options, which are critical for the long-term management of these serious diseases," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to discussing the comprehensive data package for ABP 501 with the members of the Committee."

The Committee will review analytical, clinical and pharmacokinetic data from studies involving ABP 501, including results from two Phase 3 comparative efficacy and safety studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase 3 studies met their primary endpoints showing clinical equivalence to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.

The FDA has set a Biosimilar User Fee Act (BsUFA) target action date of Sept. 25, 2016 for ABP 501.
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Source: press release, 6/13/16. http://wwwext.amgen.com/media/news-releases/2016/06/amgen-announces-fda-...

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July 12, 2016: Arthritis Advisory Committee Meeting Announcement

Center Date Time Location
CDER July 12, 2016
7:30 a.m. to 5:00 p.m. FDA White Oak Campus

10903 New Hampshire Avenue
Building 31 Conference Center
The Great Room (Rm. 1503)
Silver Spring, Maryland 20993

Agenda

The committee will discuss biologics license application 761024, for ABP 501, a proposed biosimilar to AbbVie Inc.'s HUMIRA (adalimumab), submitted by Amgen, Inc. The proposed indications (uses) for this product are: (1) Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs)); (2) reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older (alone or in combination with methotrexate); (3) reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (alone or in combination with non-biologic DMARDs); (4) reducing signs and symptoms in adult patients with active ankylosing spondylitis; (5) 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 (ABP 501 would be indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab); (6) inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP) (the effectiveness of ABP-501 would not be established in patients who have lost response to or were intolerant to TNF blockers); and (7) treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate (only to be administered to patients who will be closely monitored and have regular follow-up visits with a physician).

Meeting Materials

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: 2016 Meeting Materials, Arthritis Advisory Committee

Public Participation Information

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 June 27, 2016.
Oral presentations from the public will be scheduled between approximately 1:30 p.m. to 3:00 p.m. on July 12, 2016. 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 June 17, 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 speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 20, 2016.

Webcast Information

CDER plans to provide a free of charge, live webcast of the July 12, 2016, meeting of the Arthritis Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2016 Meeting Materials, Arthritis Advisory Committee

CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

Moon Hee V. Choi, PharmD
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993-0002
Phone: 301-796-9001
Fax: 301-847-8533
Email: AAC@fda.hhs.gov

FDA Advisory Committee Information Line 1-800-741-8138
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.
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 Moon Hee V. Choi at 301-796-9001 at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings 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).
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Source: FDA.gov. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm506845.htm

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
ABP 501 (Humira) (adalimumab) BiosimilarAutoimmune DiseaseInflamatory diseaseanti-TNF-α monoclonal antibodyTNF-α

Mechanism of action: ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases. The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).

Phase of Development: Filed

Event Type: Regulatory FDA: Advisory Committee Meeting

Dates: 2016-07-12

Results:

Results not disclosed.