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Statements and Responses

Sep. 12, 2016 Amgen Response to ICER’s Call for Comments on its Value Assessment Framework
Sep. 9, 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
Aug. 19, 2016 Amgen’s Response to ICER’s Background and Draft Scoping Document: “Disease-Modifying Anti-Rheumatic Drugs for Rheumatoid Arthritis: Effectiveness and Value”
Aug. 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"
Apr. 8, 2016 Amgen's Response to ICER's Draft Report ‘Treatment Options for Relapsed or Refractory Multiple Myeloma: Effectiveness and Value’
Jul. 1, 2016 Amgen’s Response to ICER’s Background and Draft Scoping Document: “Treatment Options for Plaque Psoriasis: Effectiveness, Value, and Value-Based Price Benchmarks”
Mar. 31, 2016 Amgen's Response to Technology Assessments for Kyprolis® (Carfilzomib) in Multiple Myeloma
Sept. 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://cepac.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
Aug. 6, 2014 Amgen Response to USA Today Article on Restructuring
May 8, 2014 Amgen Statement on EMA Review of Ivabradine
Apr. 16, 2014 Amgen Statement on FDA Fast Track Designation for Investigational Ivabradine
Apr. 3, 2014 Commercialize Prolia on Its Own in the European Union Switzerland Norway Russia and Mexico
Mar. 7, 2014 Amgen Statement on Evolocumab Proactive Monitoring
Feb. 11, 2014 Amgen Statement on Jan. 27, 2014, FDA Warning Letter
Feb. 4, 2014 Amgen Statement on Support for Sound Science-Based Biosimilar Policies
Dec. 20, 2013 Amgen Submits Comments to FDA on Biosimilars Naming Citizen Petitions
Dec. 6, 2013 Amgen Supports Distinguishable Naming Policy for Biosimilars
Oct. 12, 2013 Amgen Statement on Veto for California Biosimilars Bill
Sept. 20, 2013 Amgen Statement on GPhA Citizen Petition on Naming for Biologics
Nov. 21, 2013 Amgen Statement on Analyst Comments Concerning Kyprolis Trial Data
June 24, 2013 Amgen Response to The New England Journal of Medicine Study
June 11, 2013 Neulasta and the 340B Drug Discount Program
Apr. 22, 2013 Amgen Welcomes European Commission Report on EU Biosimilars Uptake
Apr. 17, 2013 Amgen Statement on Additional Biomarker Analysis Beyond KRAS From Completed Phase 3 Study
Apr. 8, 2013 Response to the Editorial "Building a wall against biosimilars" April 2013 Issue of Nature Biotechnology
Mar. 24, 2013 Amgen Supports World Health Organizations Proposed Distinguishable Naming Policy for Biosimilars
Feb. 22, 2013 Amgen Statement on Government Budget Analysis for Oral-Only Treatments for Dialysis Patients
Feb. 1, 2013 Amgen Response to Recent New York Times Story "Biotech Firms, Billions at Risk, Lobby States to Limit Generics"
Jan. 29, 2013 Amgen Response to Recent New York Times Stories and an Editorial That Are Based on Misunderstanding of the Facts
Jan. 16, 2013 Amgen Statement on Stroke Research



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