Amgen announced that the company will discuss data supporting the ABP 501 Biologics License Application (BLA) with the US Food and Drug Administration's (FDA) Arthritis Advisory Committee. ABP 501 is a biosimilar candidate to Humira (adalimumab), an anti-tumour necrosis factor-alpha (TNF-a) 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.

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-a 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-a monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (US) and adalimumab (EU).

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.