Tagged as: Fresenius Kabi

HUMIRA (adalimumab) Biosimilar Launches

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 (adalimumab-bwwd); Coherus Biosciences’s YUSIMRY (adalimumab-aqvh); Celltrion’s YUFLYMA (adalimumab-aaty); Fresenius Kabi’s IDACIO (adalimumab-aacf); and Biocon’s HULIO (adalimumab-fkjb).  With Amgen’s AMJEVITA (adalimumab-atto), launched in January 2023, there…

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

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 approved by the FDA on September 6, 2022 and is now Fresenius Kabi’s first biosimilar to launch in the United States. …

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An Interview with Rachel Goode, Ph.D, about Biological Patent Thickets

Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to biosimilars, an American problem.”[1]  The article, published in the Journal of Law and the Biosciences, examines whether patent…

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Fresenius Kabi Announces FDA Approval of Adalimumab Biosimilar

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 diseases for all eligible indications of the reference product and, according to Fresenius, is expected to launch in the…

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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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Fresenius Kabi Announces FDA Approval of Pegfilgrastim Biosimilar

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 myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.  The company states that it expects to launch the product in…

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FDA Accepts for Review Fresenius Kabi’s BLA for Tocilizumab Biosimilar

On August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab).  The BLA includes both subcutaneous (prefilled syringe and autoinjector) and intravenous administrations.  This is the first BLA accepted by FDA for a tocilizumab biosimilar. …

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International Biosimilar Approval and Launch Updates

On March 30, 2022, Fresenius Kabi announced that the European Commission approved STIMUFEND, a pegfilgrastim biosimilar referencing NEULASTA, for patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy.  STIMUFEND, to launch in a prefilled syringe, is Fresenius’s first approved molecule in its oncology biosimilar portfolio and second biosimilar approved in…

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Biosimilar Deal Watch: Formycon/ATHOS, Fresenius/mAbxience/Ivenix, and Intas/Axantia

It has been a busy last few weeks for biosimilar developers, with multiple deals announced. On March 29, 2022, it was announced that Formycon AG (“Formycon”) and ATHOS KG (“ATHOS”) have agreed to merge their development activities in the area of biosimilars through a long-term strategic partnership.  Formycon will acquire…

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Fresenius Files IPR Petitions Challenging Chugai/Roche/Genentech Rheumatoid Arthritis Patents

On August 18, 2021, Fresenius Kabi USA, LLC and Fresenius Kabi SwissBioSim GmbH (collectively, “Fresenius”) filed Petitions for Inter Partes Review of U.S. Patent No. 10,874,677 (IPR 2021-01336) and U.S. No. 5,80,264 (IPR 2021-01288) .  The ‘264 patent claims are directed to methods of treating rheumatoid arthritis patients using a…

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