The company believes the submission is the first adalimumab biosimilar application submitted to the EMA and represents Amgen’s first biosimilar to be submitted for approval in the European Union.
“The submission of Amgen's first biosimilar application to the EMA is an exciting milestone as we seek to expand our global patient reach,” said Sean E. Harper, M.D., 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 medicines to patients worldwide.”
ABP 501 is a biosimilar candidate to adalimumab, an anti-TNF-α monoclonal antibody, which is approved in many countries for the treatment of various inflammatory diseases.
Amgen’s MAA 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 in both studies. Data to support the transition of adalimumab patients to ABP 501 are included in the submission.