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Fresenius

Goodwin

Fresenius Announces Launch of Subcutaneous Formulation of TYENNE (tocilizumab-aazg) in the United States

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On July 2, 2024, Fresenius Kabi (“Fresenius”) announced the immediate availability of TYENNE (tocilizumab-aazg), in a subcutaneous formulation, in the United States....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 and Formycon Reach Settlement Agreement for Ustekinumab Biosimilar Candidate in Europe and Canada

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On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of 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 Launches TYENNE, The First Approved Tocilizumab Biosimilar In The European Union

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On November 1, 2023, Fresenius Kabi announced the launch of its tocilizumab biosimilar TYENNE referencing ROACTEMRA (tocilizumab) in the European Union....more

Benesch

Dialysis & Nephrology Digest - October 2023

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Federal Law increases competition in organ procurement, transplant system; NKF, ASN approve - The President signed the bipartisan bill into law on Sept. 22. The Organ Procurement and Transplantation Network (OPTN) was...more

Goodwin

Update on Recent International Biosimilar Approvals

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​​​​​​​Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU:  On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar...more

Goodwin

Formycon/Fresenius Kabi and Samsung Bioepis Settlements with J&J and Janssen Biotech regarding Ustekinumab

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On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed...more

Goodwin

HUMIRA (adalimumab) Biosimilar Launches

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​​​​​​​In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market:  Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA...more

Goodwin

Fresenius Kabi Launches STIMUFEND (pegfilgrastim-fpgk) in the United States

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​​​​​​​Last week, Fresenius Kabi announced the launch of STIMUFEND (pegfilgrastim-fpgk), a biosimilar to Amgen’s NEULASTA, in the United States. As we previously reported, STIMUFEND was Fresenius Kabi’s first biosimilar...more

Benesch

Dialysis & Nephrology Digest - January 2023 #2

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Benesch: Changes to state laws mean IL employers should review their employment practices - In IL, legislation affecting workplaces went into effect at the beginning of the year, including: ..The minimum wage was...more

Benesch

Dialysis & Nephrology Digest - January 2023

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Federal omnibus spending bill rolls back some Medicare payment cuts scheduled for 2023, 2024 - Buried within the $1.7-trillion spending package signed by the President on Dec. 29 was partial relief for a planned 4.5% cut...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

Benesch

Dialysis & Nephrology Digest - November 2022

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Benesch: DOL proposed rule aims to clarify independent contractor classification - The Department of Labor (DOL) proposes changes to the Fair Labor Standards Act to clarify the difference between an independent contractor...more

Goodwin

Fresenius Kabi Announces FDA Approval of Pegfilgrastim Biosimilar

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​​​​​​​On September 6, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved STIMUFEND (pegfilgrastim), a biosimilar referencing NEULASTA, in patients with non-myeloid malignancies receiving...more

Goodwin

PTAB Institutes Another IPR on a Tocilizumab Patent Challenged by Fresenius

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On March 3, 2022, the PTAB instituted another inter partes review of U.S. Patent Nos. 8,580,264 (“the ’264 patent”), owned by Chugai and Roche. Fresenius filed a petition for inter partes review of the ‘264 patent,...more

Goodwin

PTAB Institutes Two IPRs on Tocilizumab Patents

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Last week, the PTAB instituted inter partes review of two Chugai patents directed to methods of treating rheumatoid arthritis with a combination of tocilizumab and methotrexate. Fresenius filed petitions for inter partes...more

Goodwin

Year in Review: Top Legal Developments of 2021 Impacting Biosimilars

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As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more

Benesch

Dialysis & Nephrology Digest - March 2021

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Fresenius to defend itself from FCA suit following whistleblower allegations - A former employee alleges Fresenius engaged in arrangements with hospitals and nephrologists to ensure patient referrals to its dialysis...more

Goodwin

Recent Adalimumab Biosimilar Updates

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On February 15, 2021, Celltrion Healthcare announced that the European Commission granted marketing authorization for Yuflyma™ (CT-P17), an adalimumab biosimilar, on February 11, 2021.  Yuflyma™ was approved across all...more

Benesch

Dialysis & Nephrology Digest - September 2020 #2

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Fresenius launches suit against Gland Pharma over pain management drug patent - In a case before the U.S. District Court for the District of New Jersey, Fresenius alleges Gland Pharma infringed on its patent for the pain...more

Jones Day

SCOTUS Says “Fresenius/Simmons Preclusion Principle” Stays Alive

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The Supreme Court recently denied Chrimar Systems, Inc. (Chrimar)’s petition for certiorari seeking to overturn the Federal Circuit’s “Fresenius/Simmons preclusion principle,” under which Chrimar’s district court victory...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

Kramer Levin Naftalis & Frankel LLP

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

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

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