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FDA Approves XOLAIR to Treat Children and Adults With One or More Food Allergies

Genentech announced on February 16, 2024, that the U.S. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with Immunoglobulin E (IgE)-mediated…

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Updates on Aflibercept BPCIA Litigation

Regeneron Filed Complaint Against Amgen in C.D. Cal. Over ABP 938 Biosimilar to EYLEA On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”) alleging infringement of 32 patents under the BPCIA based on Amgen’s…

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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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Coherus to Acquire Surface Oncology

On June 16, 2023, Coherus BioSciences, Inc. and Surface Oncology, Inc. announced that they have entered into a definitive merger agreement, where, at the closing, Coherus will acquire Surface Oncology, a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment.  Coherus’ Chairman and Chief Executive Officer said…

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Biosimilar Clinical Trial Updates

On May 4, 2023, Alvotech announced the initiation of a confirmatory patient study for AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab).  The clinical study will compare the efficacy, safety, and immunogenicity of AVT05 and Simponi in adult patients with moderate to severe rheumatoid arthritis.  Per the announcement,…

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Celltrion Confirms Bioequivalence for CT-P39 Against Xolair in Interim Results of Phase 3 Study

On April 10, 2023, Celltrion confirmed the bioequivalence of CT-P39 to treat allergic asthma and chronic urticaria, through its interim results from its global phase 3 clinical trials at 24 weeks.  CT-P39 is a biosimilar referencing Xolair (ingredient: omalizumab), which is an antibody biopharmaceutical that treats allergic asthma, chronic urticaria,…

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Amneal Launches RELEUKO (filgrastim-ayow) in the United States

On November 22, 2022, Amneal Pharmaceuticals, Inc. (“Amneal”) announced the commercial launch of RELEUKO, a biosimilar referencing Neupogen.  RELEUKO is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy.  RELEUKO is Amneal’s second U.S. biosimilar launch.  As we previously reported, Amneal announced the launch of its first…

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Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

The U.S. Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition.  In July 2021, President Biden issued an Executive Order on “Promoting Competition in the American Economy,” which directed the Secretary of Health & Human Services…

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