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Pharmaceutical Industry › Fresenius › Food and Drug Administration (FDA)

Venable LLP

BiologicsHQ Monthly Injection - March 2025

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On March 17, 2025, Senators Chuck Grassley (R-IA), John Cornyn (R-TX), Richard Blumenthal (D-CT), and Richard Durbin (D-IL) re-introduced the “Affordable Prescriptions for Patients Act” (“APPA”), which previously passed the...more

Goodwin

FDA Approves Fresenius’s Denosumab Biosimilars

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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

Amgen and Fresenius Settle Denosumab BPCIA Case

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On March 7, 2025, the District Court for the District of New Jersey entered a Stipulation and Order of Dismissal Without Prejudice in view of a settlement agreement between Amgen and Fresenius Kabi resolving the BPCIA...more

Goodwin

Denosumab Biosimilar Updates - June 2024

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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

Goodwin

Fresenius Kabi Announces FDA Approval of TYENNE, a Tocilizumab Biosimilar Referencing ACTEMRA

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​​​​​​​On March 7, Fresenius Kabi announced that the FDA has approved its tocilizumab biosimilar, TYENNE (tocilizumab-aazg) for inflammatory and immune diseases indications including rheumatoid arthritis, giant cell...more

Venable LLP

Fresenius Kabi’s Actemra® biosimilar Tyenne® (tocilizumab-aazg) Approved in the U.S.

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On March 5, 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab-aazg) as a biosimilar of Chugai, Genentech and Hoffman-La Roche’s Actemra® (tocilizumab). ...more

Goodwin

Fresenius Kabi Announces FDA Approval of Adalimumab Biosimilar

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Earlier today, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved IDACIO (adalimumab-aacf), a biosimilar referencing HUMIRA. IDACIO is approved for use in the treatment of chronic autoimmune...more

Robins Kaplan LLP

Hospira, Inc. v. Fresenius Kabi USA, LLC

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Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322 (Fed. Cir. Jan. 9, 2020) (Circuit Judges Lourie, Dyk, and Moore presiding; Opinion by Lourie, J.) (Appeal from N.D. Ill., Pallmeyer, J.)....more

Herbert Smith Freehills Kramer

Delaware Confirms the High Threshold for Material Adverse Effect Claims and Interprets ‘Commercially Reasonable Efforts’

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A year after Akorn v. Fresenius (Akorn case), the first Delaware case holding that a party was entitled to terminate a merger agreement based on a material adverse effect (MAE), the Delaware Court of Chancery, in Channel...more

Robins Kaplan LLP

Hospira, Inc. v. Fresenius Kabi USA, LLC

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Case Name: Hospira, Inc. v. Fresenius Kabi USA, LLC, Civ. Nos. 16 C 651, 17 C 7903, 2018 U.S. Dist. LEXIS 212916 (N.D. Ill. Dec. 17, 2018) (Pallmeyer, J.)....more

Cadwalader, Wickersham & Taft LLP

M&A Update: Akorn Falls Far from the Tree: Delaware Chancery Court Finds a “Material Adverse Effect” for the First Time in Akorn,...

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On October 1, 2018, the Delaware Court of Chancery found in Akorn, Inc. v. Fresenius Kabi AG, et al. that Fresenius was entitled to terminate its merger agreement with Akorn. ...more

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