Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future

Health Affairs

Volumn 33, Issue 6, 2014, Pages 1048-1057

  Grabowski, Henry G ^a   Guha, Rahul ^b   Salgado, Maria ^b  

^a DUKE UNIVERSITY   (United States)

^b International Arbitration and Litigation Practice   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; ENOXAPARIN; HUMAN GROWTH HORMONE;

ARTICLE; COST CONTROL; DRUG COST; DRUG DEVELOPMENT; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; HEALTH CARE SYSTEM; HOSPITAL PHARMACY; HUMAN; MANAGED CARE ORGANIZATION; MEDICARE; PATIENT ATTITUDE; PHARMACY AND THERAPEUTICS COMMITTEE; PHYSICIAN ATTITUDE; REIMBURSEMENT; COST BENEFIT ANALYSIS; DRUG APPROVAL; ECONOMIC ASPECT; ECONOMICS; FORECASTING; LEGISLATION AND JURISPRUDENCE; SUPPLY AND DISTRIBUTION; SYNTHESIS; THERAPEUTIC EQUIVALENCE; TRENDS; UNITED STATES;

BIOSIMILAR PHARMACEUTICALS; COST SAVINGS; COST-BENEFIT ANALYSIS; DRUG APPROVAL; DRUG COSTS; ECONOMIC COMPETITION; FORECASTING; HUMANS; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84902011528     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.2013.0862     Document Type: Article

References (19)

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4. Under the Biologics Price Competition and Innovation Act, an abbreviated biosimilar submission cannot be approved for marketing until a twelve-year exclusivity period for the reference product has expired. However, the patent expiry date is the relevant factor for the products listed in Exhibit 1, given their respective introduction and patent expiry dates.
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15. The only other biosimilar product available in the period 2009-11 in Europe is Omnitrope. Similar to its experience in the United States, Omnitrope has achieved only low market shares in most EU countries.
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18. In December 2009 the Congressional Budget Office estimated that the act would reduce the federal budget by $7 billion during the period 2010-19 period. Congressional Budget Office. Letter to the Hon. Harry Reid [Internet]. Washington (DC): CBO; 2009 Dec 19 [cited 2014 Apr 28]. p. 12. Available from: http://cbo.gov/sites/default/files/cbofiles/ftpdocs/108xx/doc10868/12-19-reid_letter_managers_correction_ noted.pdf
19. Analysis on a comparable Senate bill in March 2008 estimated total US savings from biosimilars of $25 billion over a ten-year period. Congressional Budget Office. Cost estimate: S. 1695 Biologics Price Competition and Innovation Act of 2007 [Internet]. Washington (DC): CBO; 2008 Jun 25 [cited 2014 Apr 23]. Available from: http://www.cbo.gov/sites/default/files/cbofiles/ftpdocs/94xx/doc9496/s1695.pdf