Tagged as: Fresenius Kabi

Year in Review: Top Regulatory Developments of 2023

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023.  Below are some of the top regulatory developments from 2023. FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications, including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first…

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Janssen and Samsung Bioepis Settle STELARA (Ustekinumab) Litigation

Samsung Bioepis recently reported that it has signed a settlement and license agreement with Johnson & Johnson (“J&J”) in the United States relating to SB17, Samsung Bioepis’s ustekinumab biosimilar to J&J’s STELARA®. If SB17 is approved by the FDA, the license period in the United States will begin on February…

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Genentech, Roche, and Biogen Sue Dr. Reddy's and Fresenius for a Proposed Biosimilar of Rituxan in District of New Jersey

Genentech, Roche, and Biogen filed a Complaint on November 17 against Dr. Reddy’s Laboratories (“DRL”) and Fresenius in the U.S. District Court for the District of New Jersey, alleging infringement of 15 patents under the BPCIA based on DRL’s submission of an aBLA for DRL_RI, a proposed biosimilar of RITUXAN (rituximab)…

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Formycon Enjoined From Manufacturing FYB202 Biosimilar of STELARA in Germany

As previously reported, in February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize FYB202, a ustekinumab biosimilar of Janssen’s STELARA, in key global markets after successful regulatory approvals. The European Medicines Agency accepted Formycon’s Marketing Authorization Application for FYB202 on September 29, 2023. It was recently…

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Fresenius Kabi Launches TYENNE, The First Approved Tocilizumab Biosimilar In The European Union

On November 1, 2023, Fresenius Kabi announced the launch of its tocilizumab biosimilar TYENNE referencing ROACTEMRA (tocilizumab) in the European Union.  TYENNE is the first tocilizumab biosimilar available in Europe for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and…

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Update on Recent International Biosimilar Approvals

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 referencing Roche’s ROACTEMRA.  TYENNE is the first tocilizumab biosimilar approved in the EU.  TYENNE received approval for both subcutaneous (prefilled syringe…

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Celltrion Stelara (Ustekinumab) Settlement With J&J

It has been reported that Celltrion has finalized a settlement with Johnson & Johnson (“J&J”) in the United States relating to CT-P43, Celltrion’s ustekinumab biosimilar to J&J’s STELARA®, which would permit Celltrion to launch the product in the U.S. market on March 7, 2025, if approved by FDA. This settlement…

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

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 by J&J.  In February 2023, Formycon announced its entry into a global license agreement with Fresenius…

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FDA Accepts BLA for Dr. Reddy’s Rituximab Biosimilar for Review

On July 12, Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s) announced that the U.S. Food and Drug Administration (FDA) accepted for review its Biologics License Application (BLA) for DRL_RI, a biosimilar referencing RITUXAN (rituximab).  RITUXAN is currently FDA-approved for the treatment of adult patients with rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic…

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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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