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Last Updated: September 18, 2020

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Patent: 9,465,027

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Summary for Patent: 9,465,027
Title:Assays for detecting neutralizing autoantibodies to biologic therapy
Abstract: The present invention provides assays for detecting and measuring the presence or level of neutralizing and non-neutralizing autoantibodies to biologics such as anti-TNF.alpha. drug therapeutics in a sample. The present invention is useful for monitoring the formation of neutralizing and/or non-neutralizing anti-drug antibodies over time while a subject is on biologic therapy. The present invention is also useful for predicting and/or determining the cross-reactivity of neutralizing anti-drug antibodies in a subject\'s sample with alternative biologic therapies. As such, the present invention provides information for guiding treatment decisions for those subjects receiving therapy with a biologic agent and improves the accuracy of optimizing therapy, reducing toxicity, and/or monitoring the efficacy of therapeutic treatment to biologic therapy.
Inventor(s): Hauenstein; Scott (San Diego, CA), Ohrmund; Linda (San Diego, CA), Singh; Sharat (Rancho Santa Fe, CA), Wang; Shui Long (San Diego, CA)
Assignee: Nestec S.A. (Vevey, CH)
Application Number:14/144,261
Patent Claims:see list of patent claims

Details for Patent 9,465,027

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Centocor Inc REMICADE infliximab VIAL 103772 001 1998-08-24   Start Trial Nestec S.A. (Vevey, CH) 2031-07-06 RX Orphan search
Immunex ENBREL etanercept VIAL; SUBCUTANEOUS 103795 001 1998-11-02   Start Trial Nestec S.A. (Vevey, CH) 2031-07-06 RX Orphan search
Immunex ENBREL etanercept SYRINGE 103795 002 1998-11-02   Start Trial Nestec S.A. (Vevey, CH) 2031-07-06 RX Orphan search
Abbvie Inc HUMIRA adalimumab SYRINGE 125057 001 2002-12-31   Start Trial Nestec S.A. (Vevey, CH) 2031-07-06 RX search
Abbvie Inc HUMIRA adalimumab VIAL 125057 002 2002-12-31   Start Trial Nestec S.A. (Vevey, CH) 2031-07-06 RX search
Ucb Inc CIMZIA certolizumab pegol INJECTABLE; INJECTION 125160 001 2008-04-22   Start Trial Nestec S.A. (Vevey, CH) 2031-07-06 RX search
Centocor Ortho Biotech Inc SIMPONI golimumab INJECTABLE; INJECTION 125289 001 2009-04-24   Start Trial Nestec S.A. (Vevey, CH) 2031-07-06 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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