FDA Panel Scheduled to Review Amgen’s Humira Biosimilar

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.

About ABP 501

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of several 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).

About Amgen Biosimilars

Amgen Biosimilars is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients with serious illnesses. Biosimilars offer the potential to increase patient access to vital medicines, and Amgen is well positioned to leverage its 35 years of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.

For more information, visit www.amgenbiosimilars.com and follow us on www.twitter.com/amgenbiosim.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Check Also

FDA Approves ViiV Healthcare’s Rukobia, a First-in-Class Treatment for HIV in Adults with Few Treatment Options

LONDON–(BUSINESS WIRE)–ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. …