BREAST CANCER;
CANCER COMBINATION CHEMOTHERAPY;
COST CONTROL;
COST EFFECTIVENESS ANALYSIS;
DRUG COST;
DRUG INDUSTRY;
DRUG MARKETING;
GENE OVEREXPRESSION;
HEALTH CARE COST;
HUMAN;
PATENT;
PHASE 3 CLINICAL TRIAL (TOPIC);
REVIEW;
STOMACH CANCER;
UNITED STATES;
ANIMAL;
BREAST NEOPLASMS;
CHEMISTRY;
DRUG EFFECTS;
ECONOMICS;
FEMALE;
GENETICS;
ANIMALS;
ANTIBODIES, MONOCLONAL, HUMANIZED;
ANTINEOPLASTIC AGENTS;
BIOSIMILAR PHARMACEUTICALS;
BREAST NEOPLASMS;
FEMALE;
HUMANS;
PATENTS AS TOPIC;
RECEPTOR, ERBB-2;
Herceptin Full Prescribing Information Available from Last accessed 22 September 2014
Herceptin Full Prescribing Information. 2014.Available from: http://www.gene.com/download/pdf/herceptin-prescribing. pdf [Last accessed 22 September 2014]
(2014)
2
33646712747
Mechanisms of disease: Understanding resistance to HER2-targeted therapy in human breast cancer
Nahta R, Yu D, Hung MC, et al. Mechanisms of disease: understanding resistance to HER2-targeted therapy in human breast cancer. Nat Clin Pract Oncol 2006;3:269-80
Herceptin-Historical sales Available from Last accessed 15 July 2014]
Herceptin-Historical sales 1998-2008. Available from: www.gene.com/about-us/investors/historical-products-sales/herceptin [Last accessed 15 July 2014]
(1998)
6
84911464280
Roche Financial Reports from Available from [Last accessed 15 July 2014]
Roche Financial Reports from 1999-2013. Available from: www.roche.com/investos/annual-reports-archive.htm [Last accessed 15 July 2014]
(1999)
7
84911484614
Hospira wins UK case to overturn patents on Roche drug Herceptin
Available from [Last accessed 21 May 2014]
Hirschler B. Hospira wins UK case to overturn patents on Roche drug Herceptin. Reuters, 2014.Available from: http://www.reuters.com/article/2014/04/10/us-roche-hldghospira-idUSBREA3916H20140410 [Last accessed 21 May 2014]
Celltrion's Herzuma (trastuzumab) now approved in S. Korea. Biosimilar News, 2014.Available from: http://www.biosimilarnews.com/celltrions-herzumatrastuzumab-now-approved-in-s-korea [Last accessed 14 July 2014]
Hospira UK Limited v Genentech Inc. EWHC 1094 (Pat)
Hospira UK Limited v. Genentech Inc., (2014) EWHC 1094 (Pat
(2014)
12
84911484613
Hospira Biosimilars Policy. Hospira's Commitment to Adoption of Biosimilars in the United States. Available from [Last accessed 3 June 2014]
Hospira Biosimilars Policy. Hospira's Commitment to Adoption of Biosimilars in the United States. Available from: http://www.hospira.com/about-hospira/government-affairs/biosimilars-policy/index [Last accessed 3 June 2014]
13
84911474441
PlantForm Products page. Available from [Last accessed 15 July 2015]
PlantForm Products page. Available from: www.plantformcorp.com/products/aspx [Last accessed 15 July 2015]
14
84911494765
ViewPoints: amgen looks to leapfrog rivals in Herceptin biosimilar race with Phase III trial in early stage breast cancer patients. FirstWord Pharma Available from Last accessed 22 August 2014]
ViewPoints: amgen looks to leapfrog rivals in Herceptin biosimilar race with Phase III trial in early stage breast cancer patients. FirstWord Pharma. Available from: http://www.firstwordpharma.com/print/1077937?tsid=17 [Last accessed 22 August 2014]
15
84911494764
Available from Last accessed 22 August 2014]
Available from: http://clinicaltrials.gov/show/NCT01901146 [Last accessed 22 August 2014]
16
84911464278
Available from Last accessed 22 August 2014]
Available from: http://clinicaltrials.gov/show/NCT01901146 [Last accessed 22 August 2014]
17
84911474440
Pfizer to start phase III biosimilar trastuzumab trial. GaBi Online posted 6 Feb 2014.Available from [Last accessed 22 August 2014]
Pfizer to start phase III biosimilar trastuzumab trial. GaBi Online, posted 6 Feb 2014.Available from: http://www.gabionline.net/Biosimilar/News/Pfizer-tostart-phase-III-biosimilar-trastuzumabtrial [Last accessed 22 August 2014]
18
84911464277
Available from Last accessed 22 Augest 2014
Available from: http://clinicaltrials.gov/show/NCT01989676 [Last accessed 22 Augest 2014]
19
84911494763
Available from Last accessed 22 Augest 2014]
Available from: http://clinicaltrials.gov/show/NCT01989676 [Last accessed 22 Augest 2014]
20
84911484612
U.S. Patent No. 5,677,171
, vol.677, pp. 171
21
84911494762
U.S. Patent No. 6,339,142
, vol.339, pp. 142
22
84911464276
U.S. Patent No. 6,627,196
, vol.627, pp. 196
23
84911477065
U.S. Patent No. 7,074,404
, vol.74, pp. 404
24
84911484611
U.S. Patent No. 7,371,379
, vol.371, pp. 379
25
84911494760
U.S. Patent Application Publication
U.S. Patent Application Publication No US 2014-0079692-A1
26
84875138083
HER2 dimerization inhibitor pertuzumab-Mode of action and clinical data in breast cancer
Harbeck N, Beckmann MW, Rody A, et al. HER2 dimerization inhibitor pertuzumab-Mode of action and clinical data in breast cancer. Breast Care (Basel) 2013;8:49-55
Pertuzumab Full Prescribing Information Available from Last accessed 22 September 2014]
Pertuzumab Full Prescribing Information. 2013.Available from: http://www.gene.com/download/pdf/perjeta-prescribing. pdf [Last accessed 22 September 2014]
(2013)
28
84908094462
Fierce PharmaMarketing (March 19 2014 Available from [Last accessed 15 July 2014]
Stanton T. Roche's Perjeta proves a fast fave with cancer docs, but Kadcyla's a speed racer. Fierce PharmaMarketing (March 19, 2014 Available from: http://www.fiercepharmamarketing.com/story/roches-perjeta-proves-fast-fave-cancerdocs-kadcylas-speed-racer/2014-03-19 [Last accessed 15 July 2014]
Preclinical safety profile of trastuzumab emtasnsine (T-DM1): Mechanism of action of its cytotoxic component retained with improved tolerability
Poon KA, Flagella K, Beyer J, et al. Preclinical safety profile of trastuzumab emtasnsine (T-DM1): mechanism of action of its cytotoxic component retained with improved tolerability. Toxicol Appl Pharmacol 2013;273:298-313
A Study of Trastuzumab Emtansine (TDM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer (MARIANNE) Clinical Trial Protocol Registry, Roche Trials Database. Available from [Last accessed 14 July 2014]
A Study of Trastuzumab Emtansine (TDM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Patients With Metastatic Breast Cancer (MARIANNE). Clinical Trial Protocol Registry, Roche Trials Database. Available from: http://www.roche-trials.com/trialDetailsGet. action?studyNumber=BO22589 [Last accessed 14 July 2014]
33
84911484610
Congressional Budget Office Cost Estimate, S.1695 Biologics Price Competition and Innovation Act of
Congressional Budget Office Cost Estimate, S.1695 Biologics Price Competition and Innovation Act of 2007, Congressional Budget Office, 2008