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news.AbbVie has filed a patent infringement lawsuit, seeking to block Amgen from selling a copy of its Humira (adalimumab) rheumatoid arthritis drug.
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Under the lawsuit, filed in federal court in Delaware, AbbVie alleged that Amgen’s proposed ABP 501 biosimilar would infringe at least 10 of its patents.
AbbVie also noted that it reserves the right to assert as many as 51 other patents.
In its lawsuit, AbbVie said the law does not give Amgen license to infringe its patents. The company is seeking a court order to prevent Amgen from selling a copy of the drug.
Last month, the US Food and Drug Administration’s Arthritis Advisory Committee voted unanimously to support Amgen’s biosimilar for Humira.
Humira is an anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, which is approved in several regions to treat various inflammatory diseases.
The active ingredient of ABP 501 is an anti-TNF-α monoclonal antibody that has the similar amino acid sequence as adalimumab.
Amgen said ABP 501 has the same pharmaceutical dosage form and strength as adalimumab (US) and adalimumab (EU).
Humira is used for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, moderate to severe chronic psoriasis, moderate to severe hidradenitis suppurativa, and juvenile idiopathic arthritis.
It costs about $3,100 per month. Humira generated $8.4bn in sales last year.
Image: AbbVie US Headquarters. Photo: courtesy of AbbVie Inc.