Tagged as: Amgen

Amgen Launches AMJEVITA—First Biosimilar to HUMIRA in the United States

Amgen announced today the launch of AMJEVITA (adalimumab-atto), a biosimilar to AbbVie’s HUMIRA (adalimumab), in the United States.  AMJEVITA was the first HUMIRA biosimilar approved by the FDA and is now the first to be launched in the United States. AMJEVITA is approved to treat seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis in adults,…

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Janssen Files BPCIA Complaint Against Amgen Regarding Ustekinumab

On November 29, 2022, Janssen filed a BPCIA complaint in the District of Delaware against Amgen related to Amgen’s ustekinumb biosimilar ABP 654 of Janssen’s STELARA. This is Janssen’s first BPCIA case filed with respect to an ustekinumab biosimilar. Janssen alleges that its “scientists and clinicians spent decades developing STELARA…

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Amgen Releases 2022 Biosimilar Trends Report

On October 12, 2022, Amgen released its 2022 Biosimilar Trends Report. Since we posted on Amgen’s report preview in July, the total number of biosimilars that have been approved in the United States has increased from 36 to 39 (with the approval of Coherus’s CIMERLI (ranibizumab-eqrn) in August and Fresenius…

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Denosumab Clinical Trial Updates

The Big Molecule Watch is monitoring Phase III clinical trials involving denosumab biosimilars.  Here we report on the results of two recently completed studies. On June 30, 2022, a study was published showing that the efficacy of AryoGen Pharmed’s biosimilar denosumab candidate, ARYLIA, is noninferior to Amgen’s PROLIA for the…

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FDA Approves Amgen’s RIABNI™ (Rituximab-arrx) for Adults With Moderate to Severe Rheumatoid Arthritis

On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen’s RIABNI (rituximab-arrx), a biosimilar to Genentech’s RITUXAN®, in combination with methotrexate for treatment of moderate to severely active rheumatoid arthritis (RA).  RIABNI has been approved since December 2020 for treatment of adult patients with…

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