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New BPCIA Complaint: Genentech Files Suit Against Tanvex Regarding its Proposed Herceptin Biosimilar

Genentech filed a complaint yesterday against Tanvex in the U.S. District Court for the Southern District of California, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA for TX05, a proposed biosimilar of HERCEPTIN (trastuzumab).  Genentech asserts that Tanvex’s process for manufacturing TX05 infringes…

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Regeneron Files Antitrust Lawsuit Accusing Amgen of Engaging in a Persistent Exclusionary Campaign to Deny Patients Access to Praluent®

Late last week, Regeneron Pharmaceuticals, Inc. filed an antitrust complaint against Amgen Inc. in the U.S. District Court for the District of Delaware.  Regeneron alleges that “Amgen is engaged in a persistent exclusionary campaign to deny patients the life-saving benefits of [] Regeneron’s cholesterol-reducing medication, Praluent® (alirocumab).”  According to Regeneron,…

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Outlook Therapeutics to Revise Ophthalmic Bevacizumab BLA in Light of FDA Request

Outlook Therapeutics announced today that the FDA has requested additional information in order to complete the filing of the company’s BLA for LYTENAVA.  LYTENAVA, or ONS-5010, is an ophthalmic intravitreal injection formulation of bevacizumab for the treatment of wet AMD and other retinal diseases.  In response to FDA’s request, Outlook…

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Deal Watch: Henlius Licenses Rituximab and Trastuzumab Products to Abbott in Brazil

Earlier this week, Shanghai Henlius Biotech, Inc. announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay S.R.L. for the commercialization of HANLIKANG (rituximab) and HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), two products developed by Henlius, in Brazil.  According to the announcement, Abbott will pay…

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Amneal Achieves Third U.S. Biosimilar Approval with FYLNETRA (pegfilgrastim-pbbk)

Amneal announced today that the U.S. Food and Drug Administration has approved its Biologics License Application for FYLNETRA™ (pegfilgrastim-pbbk), a biosimilar referencing NEULASTA®.  FYLNETRA, developed in collaboration with Kashiv Biosciences, LLC, is used to treat neutropenia (low neutrophils which are a type of white blood cells that fight infection) which…

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Alvotech Announces Positive Top-Line Results from Clinical Trial for Ustekinumab Biosimilar

On May 24, 2022, Alvotech Holdings S.A. (“Alvotech”) announced positive top-line results from a confirmatory clinical trial for AVT04, Alvotech’s proposed biosimilar to STELARA® (ustekinumab). STELARA® is prescribed to treat a variety of inflammatory conditions, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Alvotech notes that its trial…

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JSR Life Sciences Launches New “Similis Bio” Business Division to Accelerate Biosimilar Development

JSR Life Sciences recently announced its launch of a new business division, “Similis Bio,” intended to help biosimilar drug developers “improve the efficiency and cost of biosimilar development.”  Specifically, Similis Bio will offer analytical and process development data that developers can use to “determine an appropriate biosimilar target, accelerate early…

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EMA Recommends Denying Marketing Authorization for Prestige BioPharma’s TUZNUE and HERVELOUS (trastuzumab) (UPDATE – 5/27/2022)

European Medicines Agency

On May 19, 2022, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued opinions recommending the refusal of marketing authorization for Prestige BioPharma Ltd.’s HD201, TUZNUE and its duplicate HERVELOUS, proposed trastuzumab biosimilars of Roche’s HERCEPTIN. TUZNUE and HERVELOUS are intended for the treatment of…

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Trial Scheduled for April 2024 in BMS Patent Case Against AstraZeneca Regarding Anti-PDL1 Antibodies

The District of Delaware has issued a scheduling order, setting a trial for April 2024, in Bristol Myers Squibb’s (BMS) patent case against AstraZeneca.  BMS filed its complaint against AstraZeneca on March 17, 2022, alleging infringement of eight patents related to anti-PD-L1 antibodies.  According to BMS, the case “relates to…

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