-
1
-
-
77952417326
-
-
Pub. L. No. 11-148, 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010. Pub. L. No. 111-152, 124 Stat. 1029
-
The Patient Protection and Affordable Care Act. Pub. L. No. 11-148, 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010. Pub. L. No. 111-152, 124 Stat. 1029 (2010).
-
(2010)
The Patient Protection and Affordable Care Act
-
-
-
2
-
-
69449083908
-
Potential Savings of Biogenerics in the United States
-
February
-
Miller S, Houts J. Potential Savings of Biogenerics in the United States. Express Scripts February 2007; www.express-scripts.com/research/studies/ pharmacybenefitresearch/specialtypharmacyservices/docs/ potentialSavingsBiogenericsUS.pdf.
-
(2007)
Express Scripts
-
-
Miller, S.1
Houts, J.2
-
4
-
-
78649288377
-
The Future of Generic Biologics: Should the United States "Follow-On" the European Pathway?
-
Kaldre I. The Future of Generic Biologics: Should the United States "Follow-On" the European Pathway? Duke Law and Technology Review 2008; www.law.duke.edu/journals/dltr/articles/2008dltr0009.html.
-
(2008)
Duke Law and Technology Review
-
-
Kaldre, I.1
-
5
-
-
8344222959
-
How Similar to "Biosimilars" Need to Be?
-
Schellekens H. How Similar to "Biosimilars" Need to Be? Nature Biotech. 22 2004: 1357-1358.
-
(2004)
Nature Biotech.
, vol.22
, pp. 1357-1358
-
-
Schellekens, H.1
-
6
-
-
33644952525
-
-
EMEA Committee for Medicinal Products for Human Use. 30 October
-
EMEA Committee for Medicinal Products for Human Use. Guideline on Similar Biological Medicinal Products. 30 October 2005.
-
(2005)
Guideline on Similar Biological Medicinal Products
-
-
-
7
-
-
77954900211
-
Biogeneric Regulatory Policies in China and India: A Comparison Study
-
Guise JW, Carson BM. Biogeneric Regulatory Policies in China and India: A Comparison Study. Drug Information Journal 44, 2010: 55-57.
-
(2010)
Drug Information Journal
, vol.44
, pp. 55-57
-
-
Guise, J.W.1
Carson, B.M.2
-
8
-
-
84888453532
-
New Legal Pathway for Biosimilar Creates Opportunities and Challenges for Biological Manufacturers: A Guide to the Legislation
-
Wright Bonilla JD, Beaver NA. New Legal Pathway for Biosimilar Creates Opportunities and Challenges for Biological Manufacturers: A Guide to the Legislation. Bloomberg Law Reports 3(6) 2010.
-
(2010)
Bloomberg Law Reports
, vol.3
, Issue.6
-
-
Wright Bonilla, J.D.1
Beaver, N.A.2
-
9
-
-
47349126691
-
Biosimilars: Policy, Clinical, and Regulatory Considerations
-
July
-
Gottlieb S. Biosimilars: Policy, Clinical, and Regulatory Considerations. Am. J. Health-Sys. Pharm. 65(6) 15 July 2008.
-
(2008)
Am. J. Health-Sys. Pharm.
, vol.65
, Issue.6
, pp. 15
-
-
Gottlieb, S.1
-
10
-
-
34548147147
-
Basic facts about biosimilars
-
DOI 10.1159/000105133
-
Nowicki M. Basic Facts About Biosimilars. Kidney Blood Press Res. 30, 2007: 267-272. (Pubitemid 47482057)
-
(2007)
Kidney and Blood Pressure Research
, vol.30
, Issue.5
, pp. 267-272
-
-
Nowicki, M.1
-
11
-
-
84888474567
-
The US Biosimilar Regulatory Scheme and Comparison with the European Experience: Where Do We Go from Here?
-
pharmtech.findpharma.com/pharmtech/Formulation/Next-Steps-for-the-US- Biosimilar-Regulatory-Scheme/ArticleStandard/Article/detail/711302
-
Rosen D, Lian L. The US Biosimilar Regulatory Scheme and Comparison with the European Experience: Where Do We Go from Here? Pharmaceutical Technology Sourcing and Management 7(3); pharmtech.findpharma.com/pharmtech/Formulation/ Next-Steps-for-the-US-Biosimilar-Regulatory-Scheme/ArticleStandard/Article/ detail/711302).
-
Pharmaceutical Technology Sourcing and Management
, vol.7
, Issue.3
-
-
Rosen, D.1
Lian, L.2
-
13
-
-
84888471524
-
-
Personal communication. Sky Xiaomin patent attorney, Scihead Patent Agent Co. Ltd., Guangdong, PR China
-
Personal communication. Sky Xiaomin patent attorney, Scihead Patent Agent Co. Ltd., Guangdong, PR China.
-
-
-
-
14
-
-
84888466634
-
Biosimilars Seen as a $3.7 Billion Drug Market by 2015
-
29 March
-
Biosimilars Seen as a $3.7 Billion Drug Market by 2015. Reuters 29 March 2011; www.reuters.com/article/2011/03/28/pharmaceuticals-biosimilar.
-
(2011)
Reuters
-
-
-
15
-
-
84888442612
-
Merck Buys Hanwha's Drug-Marketing Rights
-
14 June
-
Merck Buys Hanwha's Drug-Marketing Rights. 14 June 2011, WSJ on-line; http://online.wsj.com/article/SB10001424052702303714704576383063665947924.html.
-
(2011)
WSJ On-line
-
-
-
16
-
-
84888441875
-
Dealtalk: Race to Copy Biotech Drugs Creates Odd Bedfellows
-
19 July
-
Dealtalk: Race to Copy Biotech Drugs Creates Odd Bedfellows. Reuters 19 July 2011; www.reuters.com/article/2011/06/22/us-pharmaceuticals-biotech- idUSTRE75L2M020110622.
-
(2011)
Reuters
-
-
|