Statements and Responses
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03.01.2024
Update on Change Healthcare Cyberattack -
11.16.2023
LUMAKRAS® (sotorasib) Dose Comparison Study Results -
10.05.2023
Amgen Statement on FDA ODAC Meeting -
01.06.2023
Statement on FOURIER Analysis Published in BMJ Open -
08.16.2022
Statement on Drug Pricing Provisions Included in “Inflation Reduction Act” -
06.01.2022
Amgen Statement on Russia/Ukraine -
07.12.2021
Amgen Supports Industry Efforts to Address Global Access to COVID-19 Vaccines -
11.17.2020
Amgen Proudly Supports PhRMA’s New Principles on Clinical Trial Diversity -
07.20.2020
Oklahoma Health Care Authority and Amgen Enter into Value-Based Contract for Enbrel® (etanercept) -
05.07.2020
Amgen Comments On the Supreme Court of Japan Ruling On PCSK9 Patent Infringement Litigation
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10.18.2019
Amgen Comments on ICER’s Proposed Changes to the 2020 Value Assessment Framework
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09.09.2019
Amgen Comments on ICER’s Proposed Methods Adaptations For Assessments of Potential Cures and Other Transformative Therapies
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09.04.2019
Amgen Response in Support of the 2019 ESC/EAS Guidelines for the Management of Dyslipidaemias
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07.11.2019
Amgen Comments on PCSK9 Patent Litigation in Germany
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06.17.2019
Amgen Comments for ICER’s 2020 Value Assessment Framework
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06.14.2019
Helping Patients Understand the Price of Their Medicines
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05.02.2019
Amgen Reaches Settlement With Coherus in Trade Secrets Case Regarding Pegfilgrastim
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04.29.2019
Amgen Reaches Settlement Agreement To Resolve Allegations Related To Patient Assistance Programs
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02.21.2019
Amgen’s Comments on ICER’s Value-Based Price Of A Cure Collaborative: Methodological Considerations
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02.13.2019
Amgen’s Comments on ICER’s Price Increase Draft Protocol
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11.14.2019
Amgen Response in Support of the 2018 AHA/ACC Cholesterol Clinical Practice Guidelines
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07.27.2018
Amgen Statement on Pricing
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05.31.2018
Amgen Statement on Complete Response Letter from the U.S. FDA for ABP 980, a Biosimilar Candidate to Herceptin® (Trastuzumab)
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05.08.2018
Amgen Response to ICER’s Draft Evidence Report and Voting Questions on CGRP Inhibitors as Preventive Treatments for Patients with Episodic or Chronic Migraine
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03.07.2018
Amgen’s Final Summary Comments on ICER’s CAR-T Assessment
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01.19.2017
Amgen Response to ICER’s Draft Evidence Report and Voting Questions on CAR-T Therapy for B-Cell Cancers
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12.21.2017
Amgen’s Response to ICER’s Draft Scoping Document on Targeted Immunomodulators for the Treatment of Moderate-to-Severe Plaque Psoriasis: Effectiveness and Value (Condition Update)
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12.20.2017
Amgen Response to ICER’s Draft Scoping Document on
CGRP Preventive Therapy for Migraine
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11.30.2017
Amgen’s Statement on Cost Effectiveness of KYPROLIS® (carfilzomib) Compared to Velcade® (bortezomib) in Relapsed or Refractory Multiple Myeloma, Published in Expert Review of Hematology
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10.26.2017
Amgen Statement on the Economic Benefit of XGEVA® (denosumab) Versus Zoledronic Acid in the Prevention of Bone Complications in Multiple Myeloma
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10.25.2017
Amgen Provides Update on Status of Puerto Rico Operations
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10.06.2017
Amgen Provides Update on Status of Puerto Rico Operations
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10.05.2017
Amgen Statement on Appeals Court Decision on PCSK9 Antibody Patents
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09.25.2017
Amgen Response to ICER’s Proposed Adaptation of the
ICER Value Framework for the Assessment of Treatments for Ultra-Rare Conditions
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08.31.2017
Amgen Response to ICER’s Draft Scoping Document on CAR-T Therapy for B-Cell Cancers
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06.30.2017
Amgen’s Position on Orphan Drugs and ICER’s Orphan Drug Assessment
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06.02.2017
Amgen’s Response to the Institute for Clinical and Economic Review (ICER) Draft Report on Anabolic Therapies for Osteoporosis in Postmenopausal Women: Effectiveness and Value
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05.05.2017
Amgen Response to ICER's Updated Value Assessment Framework - Recommendations for Value Assessment of PCSK9 Inhibitors
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04.27.2017
Amgen Statement and Response to ICER Revised Value Framework Proposal and Osteoporosis Revised Scoping Document
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04.23.2017
Amgen Response to Washington State Health Technology Assessment (HTA) Program's Draft Evidence Report on the Treatment of Chronic Migraines and Chronic Tension-type Headache
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04.03.2017
Amgen’s Response to ICER’s Call for Comments on its “Updated” Value Framework - Executive Summary
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02.16.2017
Amgen Statement and Response to ICER Rheumatoid Arthritis Draft Evidence Report
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12.28.2016
Amgen Introduces New Value-Based Pharmacy Benefits Insurance Provision for U.S. Staff Members
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10.20.2016
Amgen Response to ICER Plaque Psoriasis Draft Evidence Report
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09.12.2016
Amgen Response to ICER’s Call for Comments on its Value Assessment Framework
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09.09.2016
Amgen Statement on the Clinical and Economic Value of BLINCYTO® (Blinatumomab) in Treating Adults With Relapsed or Refractory Philadelphia Chromosome Negative B-Cell Precursor Acute Lymphoblastic Leukemia
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08.19.2016
Amgen’s Response to ICER’s Background and Draft Scoping Document: “Disease-Modifying Anti-Rheumatic Drugs for Rheumatoid Arthritis: Effectiveness and Value”
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08.16.2016
Amgen Statement Regarding PCSK9 Economic Analysis Published in JAMA: "Cost-effectiveness of PCSK9 Inhibitor Therapy in Patients With Heterozygous Familial Hypercholesterolemia or Atherosclerotic Cardiovascular Disease"
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07.26.2016
Amgen Response to the Proposed ICER Review of Treatments for Rheumatoid Arthritis (RA) and Psoriatic Arthritis (PsA) "Open Input"
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04.08.2016
Amgen's Response to ICER's Draft Report ‘Treatment Options for Relapsed or Refractory Multiple Myeloma: Effectiveness and Value’
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07.01.2016
Amgen’s Response to ICER’s Background and Draft Scoping Document: “Treatment Options for Plaque Psoriasis: Effectiveness, Value, and Value-Based Price Benchmarks”
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03.31.2016
Amgen's Response to Technology Assessments for Kyprolis® (Carfilzomib) in Multiple Myeloma
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09.28.2015
Amgen Response to The Institute for Clinical and Economic Review (ICER) Draft Report on Effectiveness, Value, and Pricing Benchmarks for PCSK9 Inhibitors for High Cholesterol
Additional Background
Draft report released by ICER for public comment:
http://icer-review.org/wp-content/uploads/2015/04/PCSK9_Draft_Report_0908152.pdf
Comments from the National Pharmaceutical Council in response to the ICER Value Framework: http://www.icer-review.org/wp-content/uploads/2014/01/NPC-ICER-Framework-Slides.pdf -
08.06.2014
Amgen Response to USA Today Article on Restructuring
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05.08.2014
Amgen Statement on EMA Review of Ivabradine
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04.16.2014
Amgen Statement on FDA Fast Track Designation for Investigational Ivabradine
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04.03.2014
Commercialize Prolia on Its Own in the European Union Switzerland Norway Russia and Mexico
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03.07.2014
Amgen Statement on Evolocumab Proactive Monitoring
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02.11.2014
Amgen Statement on Jan. 27, 2014, FDA Warning Letter
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02.04.2014
Amgen Statement on Support for Sound Science-Based Biosimilar Policies
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12.20.2013
Amgen Submits Comments to FDA on Biosimilars Naming Citizen Petitions
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12.06.2013
Amgen Supports Distinguishable Naming Policy for Biosimilars
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10.12.2013
Amgen Statement on Veto for California Biosimilars Bill
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09.20.2013
Amgen Statement on GPhA Citizen Petition on Naming for Biologics
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11.21.2013
Amgen Statement on Analyst Comments Concerning Kyprolis Trial Data
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06.24.2013
Amgen Response to The New England Journal of Medicine Study
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06.11.2013
Neulasta and the 340B Drug Discount Program
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04.22.2013
Amgen Welcomes European Commission Report on EU Biosimilars Uptake
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04.17.2013
Amgen Statement on Additional Biomarker Analysis Beyond KRAS From Completed Phase 3 Study
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04.08.2013
Response to the Editorial "Building a wall against biosimilars" April 2013 Issue of Nature Biotechnology
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03.24.2013
Amgen Supports World Health Organizations Proposed Distinguishable Naming Policy for Biosimilars
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02.22.2013
Amgen Statement on Government Budget Analysis for Oral-Only Treatments for Dialysis Patients
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02.01.2013
Amgen Response to Recent New York Times Story "Biotech Firms, Billions at Risk, Lobby States to Limit Generics"
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01.29.2013
Amgen Response to Recent New York Times Stories and an Editorial That Are Based on Misunderstanding of the Facts
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01.16.2013
Amgen Statement on Stroke Research
Opinion Pieces
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08.25.2016
Amgen Letter Submitted to JAMA Editor
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08.19.2016
Cost-Effectiveness Model Greatly Exaggerates Costs of PCSK9 Inhibitors – Cardiology Today
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08.18.2016
Flawed JAMA Study Misrepresents Costs And Benefits Of New Cholesterol Drugs – Stat
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08.18.2016
JAMA Report On Cholesterol Drugs Fails Reliability Test – Medscape
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08.18.2013
USA Today: New cholesterol drugs could add $120 billion to annual U.S. health costs – USA Today
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03.18.2013
Submitted to the Editor – Los Angeles Times
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02.13.2013
Submitted to the Editor – Denver Post
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02.12.2013
Submitted to the Editor – New York Times
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01.29.2013
Submitted to the Editor – New York Times
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01.28.2013
Submitted to the Editor – New York Times