Drug regulation and pricing - Can regulators influence affordability?

New England Journal of Medicine

Volumn 374, Issue 19, 2016, Pages 1807-1809

  Eichler, Hans Georg ^a,b   Hurts, Hugo ^a,c   Broich, Karl ^a,d   Rasi, Guido ^a,e  

^a EUROPEAN MEDICINES AGENCY   (United Kingdom)

^b MEDICAL UNIVERSITY OF VIENNA   (Austria)

^c Medical University of Vienna ^*  (Netherlands)

^d Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte   (Germany)

^e UNIVERSITY OF ROME TOR VERGATA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; GENERIC DRUG; DRUG;

BIOTECHNOLOGY; COMMERCIAL PHENOMENA; COST BENEFIT ANALYSIS; COST CONTROL; DRUG APPROVAL; DRUG COST; DRUG DEVELOPMENT; DRUG EFFICACY; DRUG INDUSTRY; DRUG LEGISLATION; DRUG QUALITY; DRUG RESEARCH; EUROPEAN UNION; FINANCIAL MANAGEMENT; GOVERNMENT REGULATION; PRIORITY JOURNAL; REIMBURSEMENT; REVIEW; RISK BENEFIT ANALYSIS; DRUG CONTROL; ECONOMIC ASPECT; ECONOMICS; EUROPE; MEDICAL RESEARCH; ORGANIZATION AND MANAGEMENT; STANDARDS;

BIOMEDICAL RESEARCH; DRUG AND NARCOTIC CONTROL; DRUG APPROVAL; DRUG COSTS; DRUG DISCOVERY; DRUG INDUSTRY; DRUGS, GENERIC; ECONOMIC COMPETITION; EUROPE; GOVERNMENT REGULATION; PHARMACEUTICAL PREPARATIONS;

EID: 84966588586     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1601294     Document Type: Review

References (5)

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2. Fein AJ. What Gilead's big hepatitis C discounts mean for biosimilar pricing. Drug Channels. February 5, 2015 (http://www .drugchannels .net/2015/02/what-gileads-big-hepatitis-c-discounts .html).
3. Senior M. Heart drug pushes outcomebased pricing plans. Nat Rev Drug Discov 2015; 14: 665-7.
4. European Medicines Agency. Reflection paper on risk based quality management in clinical trials. August 4, 2011 (http://www .ema .europa .eu/docs/en-GB/document-library/Scientific-guideline/2011/08/WC500110059 .pdf).
5. Eichler HG, Baird LG, Barker R, et al. From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients. Clin Pharmacol Ther 2015; 97: 234-46.