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Fresenius Amgen FDA Approval

Venable LLP

March Stelara® Biosimilar Launches: Fresenius Kabi’s Otulfi® and Celltrion’s Steqeyma™

Venable LLP on

On March 3, 2025, Fresenius Kabi and Formycon announced the launch of Otulfi™ (ustekinumab-aauz), a provisionally interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), subject to the...more

Goodwin

FDA Approves Fresenius’s Denosumab Biosimilars

Goodwin on

On March 26, 2025, the FDA approved Fresenius Kabi’s denosumab biosimilars, CONEXXENCE® (denosumab-bnht) and BOMYNTRA® (denosumab-bnht), referencing Amgen’s PROLIA® and XGEVA®, respectively.  These approvals make Fresenius...more

Goodwin

Denosumab Biosimilar Updates - June 2024

Goodwin on

On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Denosumab, sold by Amgen under the...more

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