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Fresenius Kabi Announces Launch of TYENNE, a Tocilizumab Biosimilar Referencing ACTEMRA

On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation.  As we previously reported, Fresenius Kabi received FDA approval for both intravenous and subcutaneous formulations on March 5, 2024, making TYENNE the first tocilizumab biosimilar approved in both formulations.  TYENNE is…

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

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 arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.  TYENNE is the second FDA approved biosimilar of ACTEMRA (following Biogen’s TOFIDENCE (tocilizumab-bavi)…

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Regeneron’s Disputes with Celltrion, Samsung Bioepis, and Formcycon on Service and Personal Jurisdiction in Aflibercept BPCIA Litigation

As we have previously reported, in November 2023 Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed complaints against Celltrion,  Samsung Bioepis and Formycon (collectively, “the Defendants”) in the U.S. District Court for the Northern District of West Virginia, alleging patent infringement under the Biologics Price Competition and Innovation Act (“BPCIA”) based on the…

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Genentech and Biogen File Joint Stipulation of Dismissal in BPCIA Litigation Regarding Tocilizumab

As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts, asserting that Biogen sought FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra®…

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Update on mRNA Vaccine Patent Litigation

We previously reported on patent infringement litigations between Alnylam and Moderna.  Below we provide updates on two proceedings involving the mRNA vaccine producer Moderna. First, in a patent action brought by Alnylam Pharmaceuticals, Inc. (“Alnylam”) against Moderna, Inc., ModernaTX, Inc., and Moderna US, Inc. (collectively, “Moderna”), the parties entered a…

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FDA Issues Draft Guidance on Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products and Classification Categories for Certain Supplements under BsUFA III

In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products” and “Classification Categories for Certain Supplements under BsUFA III”, respectively. The “Formal Meetings between the FDA and…

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Genentech and Tanvex Reach Settlement in Principle in Trastuzumab BPCIA Litigation

On January 6, 2023, Genentech and Tanvex reached a settlement in principle to resolve all claims with respect to Genentech’s BCPIA complaint.  As we previously reported, Genentech filed a complaint against Tanvex in June 2022, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA…

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Genentech Voluntarily Recalls SUSVIMO (ranibizumab)

This month, Genentech announced a voluntary recall of the ranibizumab injection (SUSVIMO) ocular implant and associated insertion tool.  SUSVIMO, which provides continuous administration of the anti-VEGF (vascular endothelial growth factor A) monoclonal antibody fragment ranibizumab, is approved by the FDA for treatment of wet age-related macular degeneration.  According to Genentech,…

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