Amgen's first biosimilar Biologics License Application for ABP 501 submitted To FDA

Supported by Phase III studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis.

"The submission of Amgen's first biosimilar application to the FDA is an exciting milestone, expanding our inflammation portfolio to provide additional therapeutic options to patients," said Sean E. Harper, executive vice president of R&D at Amgen. "Patients with chronic inflammatory conditions are faced with a significant burden of disease requiring long-term treatment. Amgen's branded biologic medicines and biosimilars are developed and manufactured according to the same high standards, and we are committed to delivering high-quality medicines to patients with serious inflammatory diseases."

ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-a monoclonal antibody, which is approved in many countries for the treatment of various inflammatory diseases.

Amgen's BLA submission includes analytical, clinical and pharmacokinetic data. Phase III comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The Phase III 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.