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By W. Randy Kubetin
Nov. 25 — Amgen Inc. announced Nov. 25 that it has submitted a biologics license application to the FDA for ABP 501, a biosimilar of AbbVie's top-selling arthritis drug Humira (adalimumab).
Amgen said it believes this is the first adalimumab biosimilar application submitted to the Food and Drug Administration, and noted that it's Amgen's first BLA submission using the Section 351(k) biosimilar approval pathway under the Biologics Price Competition and Innovation Act.
“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,” Sean E. Harper, executive vice president of research and development at Amgen, said in a statement.
Adalimumab is an anti-TNF-α monoclonal antibody approved in many countries for treating various inflammatory diseases. Humira is AbbVie's top-selling drug, with estimated 2015 sales of $14 billion, according to Bloomberg data.
Amgen said its 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, Amgen said, and safety and immunogenicity of ABP 501 were also comparable to adalimumab.
The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the same amino acid sequence as adalimumab, Amgen said. ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU), the company said.
According to the FDA, a biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. In March, the FDA approved the first biosimilar in the U.S. That biosimilar product is Zarxio, a Sandoz biosimilar of an Amgen reference product, Neupogen (filgrastim).
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