Europeans recommend approval of Amgen’s biosimilar of AbbVie’s Humira
The European Medicines Agency recommended the approval of the ABP 501, a biosimilar of AbbVie’s Humira (adalimumab), for treatment of inflammatory diseases, Thousand Oaks-based biotech company Amgen announced on Jan. 27.
The EMA recommended ABP 501’s use for moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis, severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, moderate-to-severe hidradenitis suppurativa, non-infectious intermediate, posterior and panuveitis, moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis.
“The positive opinion for ABP 501 marks the first time an adalimumab biosimilar has been recommended for approval in the EU,” said Dr. Sean Harper, Amgen executive vice president of research and development. “This represents another significant milestone for our biosimilars portfolio and is an important step in our effort to develop high-quality biologic medicines for patients suffering from chronic inflammatory diseases.”
If approved, marketing authorization will be granted in the European Union.
ABP 501 was approved in the United States by the U.S. Food and Drug Administration on Sept. 23, where it goes by the brand name Amjevita.
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