scholarly journals Clinical and treatment characteristics of patients treated with the first therapeutic oncology biosimilars bevacizumab-awwb and trastuzumab-anns in the US

2021 ◽  
Vol 13 ◽  
pp. 175883592110419
Author(s):  
Ran Jin ◽  
Reshma L. Mahtani ◽  
Neil Accortt ◽  
Tatiana Lawrence ◽  
Darcie Sandschafer ◽  
...  
Keyword(s):  
Market Entry ◽  
Reference Product ◽  
Early Stage ◽  
Patient Characteristics ◽  
Cancer Management ◽  
The Us ◽  
The Usa ◽  
Previously Treated ◽  
Tumor Types ◽  
Video Abstract

Background: In July 2019, bevacizumab-awwb and trastuzumab-anns were marketed in the USA as the first therapeutic oncology biosimilars. We aimed to investigate the initial real-world use of bevacizumab-awwb and trastuzumab-anns for cancer management in US oncology practices. Methods: A retrospective, observational analysis of data from US cancer patients (⩾18 years of age) was carried out to describe the use of bevacizumab-awwb and trastuzumab-anns during the first 12 months following their market entry, using structured data from the Flatiron Health electronic health record-derived database. Results: A total of 2952 and 2997 patients with recorded use of bevacizumab-awwb and trastuzumab-anns, respectively, were included in the analysis. The first use of bevacizumab-awwb and trastuzumab-anns was in a patient with metastatic colorectal cancer (mCRC) within 10 days of market availability and in a patient with early stage breast cancer (eBC) within 4 days, respectively. The use of these biosimilars was observed across all approved cancer indications; 68% of bevacizumab-awwb users were those diagnosed with mCRC and 72% of trastuzumab-anns users were those diagnosed with eBC. Approximately half the patients were previously exposed to reference product (RP) prior to initiation of bevacizumab-awwb or trastuzumab-anns. Among pre-exposed patients, the majority received the biosimilars [bevacizumab-awwb (63–85%) or trastuzumab-anns (75–81%)] within 28 days of the last infusion of the RP. For both biosimilars, no major differences were observed in patient characteristics between RP-naïve and pre-exposed patients. Conclusion: Initial evidence from the first 12 months following market entry suggests rapid clinical adoption of bevacizumab-awwb and trastuzumab-anns across all approved tumor types. Usage of these two biosimilars was observed in both RP-naïve patients and patients who were previously treated with RP, with no distinctive differences in patient characteristics between the two groups. A video abstract is available for this article as part of the Kanjintionline supplemental material.

What the patent dance of the Biosimilars Act means for biosimilars

2014 ◽  
Vol 20 (4) ◽  
Author(s):  
David A. Fazzolare ◽  
Joanna Brougher
Keyword(s):  
Price Competition ◽  
Market Entry ◽  
Patent Protection ◽  
Reference Product ◽  
Title Vii ◽  
President Obama ◽  
Biological Products ◽  
Related Information ◽  
The Us ◽  
Biologic Product

There are currently only two biosimilars on the market in the US in contrast to the 21 biosimilars have been approved in Europe since 2006. Part of the reason for the lack of biosimilars is that until recently, there has been no abbreviated pathway for a biosimilar to reach the market meaning that biosimilars had to undergo the long and costly process of obtaining approval just like an innovator biologic product. After years of negotiation, however, the Biologics Price Competition and Innovation Act (the “Biosimilars Act”) was signed into law on March 23, 2010, by President Obama as Title VII of the Patent Protection and Affordable Care Act. The Biosimilars Act established an abbreviated pathway by which the FDA could approve generic versions of previously licensed biological products. The Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called “Patent Dance” which describes the process by which the biosimilar applicant and the reference product sponsor (“RPS”) exchange patent-related information before the biosimilar can enter the market. In this article, we will explore what the Patent Dance is and what it means for biosimilars that are seeking market entry in the US. 

SEER-Medicare study of early-stage triple-negative breast cancer: Real-world treatment patterns, survival, and expenditures 2010 to 2016.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12512-e12512
Author(s):  
Jan Sieluk ◽  
Amin Haiderali ◽  
Min Huang ◽  
Lingfeng Yang ◽  
Konstantinos Tryfonidis ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Radiation Therapy ◽  
Elderly Patients ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Early Stage ◽  
Patient Characteristics ◽  
Breast Cancers ◽  
The Us ◽  
Poor Outcomes

e12512 Background: In the US, triple-negative breast cancer (TNBC) represents about 10–20% of breast cancers. Current information about the clinical and economic burden of early-stage TNBC in elderly patients is lacking. Methods: We used the SEER-Medicare database to identify patients with continuous Medicare Parts A/B enrollment, ≥66 years old, newly diagnosed between 2010 - 2015 (followed until 2016) with stage II-III TNBC, who initiated systemic neoadjuvant and/or adjuvant (including chemotherapy and radiation) therapy. Overall survival (OS) and event-free survival (EFS) from diagnosis were estimated using Kaplan-Meier (KM). Healthcare costs were determined during neoadjuvant and adjuvant periods. Results: Of 1569 patients ( > 99% women), 94 (6%) received neoadjuvant therapy, 1162 (74%) received adjuvant therapy, and 313 (20%) received both (neo/adj; Table). Age and race/ethnicity distributions were comparable in the three cohorts. Primary tumor T stage was T1c/T2 for 43%, 83%, and 58% in neoadjuvant, adjuvant, and neo/adj, respectively, and T3 for 14%, 10%, and 15%, respectively. The most common systemic regimens in both neoadjuvant and adjuvant periods were a taxane +/- anthracycline; 21% and 67% of patients in adjuvant and neo/adj cohorts received radiation therapy after surgery. Most claims were for outpatient treatment; hospitalizations were uncommon. The total mean expenditures per patient per month were US$10,620 and $24,408 during neoadjuvant and adjuvant periods, respectively. Conclusions: This study provides insights into patient characteristics, as well as clinical and economic outcomes for elderly patients with early-stage TNBC, treated from 2010-2016 in the US, highlighting the high monetary burden of TNBC and poor outcomes associated with stage III patients. [Table: see text]

Initial experience of patients treated in a real-world clinical setting with bevacizumab-awwb: The first FDA-approved biosimilar to bevacizumab.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 81-81
Author(s):  
Ran Jin ◽  
Neil A Accortt ◽  
Darcie Sandschafer ◽  
Tatiana Lawrence ◽  
Arturo Loaiza-Bonilla
Keyword(s):  
Real World ◽  
Clinical Characteristics ◽  
Reference Product ◽  
Previous Treatment ◽  
The United States ◽  
Product Launch ◽  
Cancer Management ◽  
Level Data ◽  
Nsclc Patients ◽  
Tumor Types

81 Background: Bevacizumab-awwb is the first anti-cancer biosimilar and the first biosimilar to bevacizumab approved by the FDA. It was launched in the United States on July 19, 2019. Bevacizumab-awwb approval was based on a phase 3 study in a pre-determined sensitive population of non-squamous non-small cell lung cancer (NSCLC) patients. This study investigated initial use of bevacizumab-awwb, across its approved indications for advanced cancer management, in real-world US community and academic oncology practices. Methods: This retrospective observational study described demographic and clinical characteristics of patients who received bevacizumab-awwb using structured patient-level data from the nationwide de-identified Oncology Services Comprehensive Electronic Records (OSCER), a Flatiron Health EHR-derived database. The database is longitudinal, demographically and geographically diverse, and includes more than 2.2 million US cancer patients from >280 cancer clinics. This analysis included adult patients who received ≥1 bevacizumab-awwb infusion between July 30, 2019 and April 30, 2020 and focused on describing initial biosimilar uptake in cancer patient populations beyond NSCLC. Results: First use of bevacizumab-awwb was in mCRC and occurred within 10 days of product launch. All bevacizumab-awwb approved cancer indications were represented among 2,422 patients treated with bevacizumab-awwb. Initial use of bevacizumab-awwb across indications: mCRC (68%), NSCLC (14%), brain cancer (11%), cervical cancer (5%), metastatic renal cell carcinoma (1%). Among 1657 mCRC patients treated with bevacizumab-awwb, 55% were male with a median age of 65 years (y). Most patients were white (60%), with ECOG scores of 0/1 (84%), and median body weight was 78 kg. Among mCRC patients, 59% had received the reference product before receiving the biosimilar. Among patients with other tumor types, 42-50% had prior bevacizumab exposure. Among mCRC patients with prior exposure to bevacizumab, 67% received bevacizumab-awwb within 28 days of last infusion of reference product (Table). Demographic and clinical characteristics were comparable between patients with and without prior bevacizumab use. Conclusions: Early evidence suggests physicians are comfortable initiating or transitioning patients to the first FDA-approved biosimilar to bevacizumab, with little evidence that demographic characteristics differ between patients with and without previous treatment with bevacizumab. Future analyses will determine whether these patterns persist across all indications. [Table: see text]

scholarly journals AB0329 PHYSICIANS’ PRE-LAUNCH AWARENESS AND CONCERNS WITH PIPELINE JANUS KINASE INHIBITORS (JAKIS) VERSUS TOFACITINIB AND BARICITINIB IN RHEUMATOID ARTHRITIS IN THE UNITED STATES AND EUROPE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1463.1-1463
Author(s):  
D. Baldock ◽  
G. Giannakopoulou
Keyword(s):  
Rheumatoid Arthritis ◽  
Kinase Inhibitors ◽  
Patient Characteristics ◽  
The United States ◽  
Janus Kinase ◽  
Personal Awareness ◽  
Medical Chart Review ◽  
The Us ◽  
The Usa ◽  
The Eu

Background:Clinical data regarding use of tofacitinib and baricitinib in rheumatoid arthritis patients have recently posed safety concerns, with regulatory bodies suggesting limiting use of higher dosages. Investigating physicians’ awareness and views of each of these products leading up to their launch, as well as the physicians’ patient characteristics, may provide evidence of how pipeline JAKis could be received in the treatment landscape once approved.Objectives:The objective of the study was to investigate awareness and anticipated concerns of upcoming versus already launched JAKis among a sample of treating rheumatologists in the US and EU5 countries, and assess potential correlation between sampled physicians’ views on JAKis and their managed patient characteristics.Methods:A multi-country, multi-center online medical chart review study of patients with RA was conducted across 2011 – 2019 among rheumatologists in hospitals and private practices to collect de-identified data on a sample of patients who were recently treated with a biologic/JAKi in the USA & EU5 (UK, France, Italy, Spain, Germany). Physicians were screened for duration of practice (3-30 years) and patient volume (≥2 RA biologic/JAKi patients per week) and recruited from a large, geographically representative access panel. Patient charts were recorded for the next 5 eligible patients seen during the screening period. Respondents abstracted patient demographics and personal awareness and concerns for drugs in development. Sites waived local ethics review owing to collection of retrospective de-identified data. Data were analyzed using descriptive statistics.Results:In Q1 19, 56.2% and 56.2% of sampled US physicians were aware of upadacitinib (upa) and filgotinib (filgo), respectively1. Prior to US launch, tofacitinib (tofa) and baricitinib (bari) achieved respective awarenesses of 89.9% (Q4 11, n = 109)2and 85.2% (Q2 17, n= 101)3. Among 262 sampled EU5 rheumatologists, pre-launch awareness in of upa and filgo in Q1 19 was 46.2% and 45.8%1, while for tofa and bari it was 46.2% and 45.8%, respectively (Q2 16, n= 380)4. ‘Poor safety profile’ was cited as a common anticipated concern for upa and filgo, 9.9% of sampled physicians aware of upa (n=121) and 7.5% of those aware of filgo (n=120)1, with the respective scores for tofa and bari prior to their launch being 16.9% (n = 296) and 14.5% (n= 227)4. Sampled patient characteristics in each physician segment (upa concerned n= 449 patients /non-concerned, n= 155 patients; filgo concerned, n= 454 patients /non-concerned, n= 145 patients) included: (a) age in years 54.6/51, p<0.01; 53.9/51.2, p<0.05 (b) retired employment status 31%/20.6%, p<0.05; 29.5%/20%, p<0.051.Conclusion:In this sample, upa and filgo achieved lower awareness scores, compared to tofa and bari prior their launch. Sampled EU5 physicians were less concerned with upa and filgo’s safety profiles, than for the other two JAKis before launch. Sampled physicians holding concerns with upa/filgo manage significantly older patients and a significantly higher number of retired patients. Further investigation using comparator cohort is warranted.References:[1]Ipsos Global Rheumatoid Arthritis Therapy Monitor (Q1 2019, 262 sampled rheumatologists in the EU and 115 sampled rheumatologists in the US reporting on a sample of RA patients seen in their practice; data collected online).[2]Ipsos Global Rheumatoid Arthritis Therapy Monitor (Q4 2011, 109 sampled rheumatologists in the US reporting on a sample of RA patients seen in their practice; data collected online).[3]Ipsos Global Rheumatoid Arthritis Therapy Monitor (Q2 2017, 101 sampled rheumatologists in the US reporting on a sample of RA patients seen in their practice; data collected online).[4]Ipsos Global Rheumatoid Arthritis Therapy Monitor (Q2 2016, 380 sampled rheumatologists in the EU reporting on a sample of RA patients seen in their practice; data collected online).© Ipsos 2020, all rights reservedDisclosure of Interests:None declared

Measurement Invariance of a Universal Behavioral Screener Across Samples From the USA and Germany

2018 ◽  
Vol 34 (2) ◽  
pp. 87-100 ◽  
Author(s):  
Gino Casale ◽  
Robert J. Volpe ◽  
Brian Daniels ◽  
Thomas Hennemann ◽  
Amy M. Briesch ◽  
...  
Keyword(s):  
Measurement Invariance ◽  
Student Behavior ◽  
Cross Cultural ◽  
Cross Cultural Comparison ◽  
School Based ◽  
Cultural Research ◽  
Universal Screener ◽  
Confirmatory Factor ◽  
The Us ◽  
The Usa

Abstract. The current study examines the item and scalar equivalence of an abbreviated school-based universal screener that was cross-culturally translated and adapted from English into German. The instrument was designed to assess student behavior problems that impact classroom learning. Participants were 1,346 K-6 grade students from the US (n = 390, Mage = 9.23, 38.5% female) and Germany (n = 956, Mage = 8.04, 40.1% female). Measurement invariance was tested by multigroup confirmatory factor analysis (CFA) across students from the US and Germany. Results support full scalar invariance between students from the US and Germany (df = 266, χ2 = 790.141, Δχ2 = 6.9, p < .001, CFI = 0.976, ΔCFI = 0.000, RMSEA = 0.052, ΔRMSEA = −0.003) indicating that the factor structure, the factor loadings, and the item thresholds are comparable across samples. This finding implies that a full cross-cultural comparison including latent factor means and structural coefficients between the US and the German version of the abbreviated screener is possible. Therefore, the tool can be used in German schools as well as for cross-cultural research purposes between the US and Germany.

Sanctions of the USA and the Policy of Bank of Russia:double Blow to the National Economy

2014 ◽  
pp. 13-29 ◽  
Author(s):  
S. Glazyev
Keyword(s):  
National Security ◽  
Economic Sanctions ◽  
Capital Flight ◽  
Practical Advice ◽  
The Us ◽  
Monetary Authorities ◽  
The Usa ◽  
Simultaneous Adoption ◽  
The Eu

This article examines fundamental questions of monetary policy in the context of challenges to the national security of Russia in connection with the imposition of economic sanctions by the US and the EU. It is proved that the policy of the Russian monetary authorities, particularly the Central Bank, artificially limiting the money supply in the domestic market and pandering to the export of capital, compounds the effects of economic sanctions and plunges the economy into depression. The article presents practical advice on the transition from external to domestic sources of long-term credit with the simultaneous adoption of measures to prevent capital flight.

Possibility of Using in Russia the Experience of LED Lighting Application at the USA Airfields

2019 ◽  
pp. 71-77
Author(s):  
Vladimir V. Vorozhikhin ◽  
Eugenia L. Moreva ◽  
Vladimir G. Starovoytov ◽  
Igor G. Tyutyunnik
Keyword(s):  
Air Transportation ◽  
Improve Quality ◽  
Led Lighting ◽  
The Us ◽  
The Usa ◽  
Quality And Reliability ◽  
Lighting Application

The purpose of this paper is an investigation of LEDs illumination experience at US-based aerodromes with an assessment of its feasibility and its necessity in Russia. The following methods were used: the analysis of aerodrome lighting requirements; the review and the analysis of development features in aerodrome LEDs illumination; the experience analysis of LEDs illumination of US-based aerodromes; the deductive analysis and the assessment synthesis of feasibility and necessity of US experience in LEDs illumination at Russian-based aerodromes. The following results were achieved: – The analysis of issues and opportunities was conducted for development of LEDs illumination at US-based aerodromes and of American experts’ recommendations for its use; – The cases were taken for use and assessment of development in LEDs illumination at US-based aerodromes; – The review and the analysis were conducted in relation to a developing market of LEDs illumination at Russian-based aerodromes. The main conclusion is that the US experience will improve quality and reliability of service provided in air transportation, comfort, and safety of Russian flights, as well as competitiveness of Russian- based airports and airlines (indirectly).

Interaction of Ukrainian Diaspora and the USA Government Regarding Celebration of Ukrainian Independence Day on January 22

2018 ◽  
Vol 1 (47) ◽  
pp. 136-145
Author(s):  
Halyna Shchyhelska
Keyword(s):  
United States ◽  
House Of Representatives ◽  
The United States ◽  
100Th Anniversary ◽  
Totalitarian Regime ◽  
The Public ◽  
Us Congress ◽  
The Us ◽  
Public Consciousness ◽  
The Usa

2018 marks the 100th anniversary of the proclamation of Ukrainian independence. OnJanuary 22, 1918, the Ukrainian People’s Republic proclaimed its independence by adopting the IV Universal of the Ukrainian Central Rada, although this significant event was «wiped out» from the public consciousness on the territory of Ukraine during the years of the Soviet totalitarian regime. At the same time, January 22 was a crucial event for the Ukrainian diaspora in the USA. This article examines how American Ukrainians interacted with the USA Government institutions regarding the celebration and recognition of the Ukrainian Independence day on January 22. The attention is focused on the activities of ethnic Ukrainians in the United States, directed at the organization of the special celebration of the Ukrainian Independence anniversaries in the US Congress and cities. Drawing from the diaspora press and Congressional Records, this article argues that many members of Congress participated in the observed celebration and expressed kind feelings to the Ukrainian people, recognised their fight for freedom, during the House of Representatives and Senate sessions. Several Congressmen submitted the resolutions in the US Congress urging the President of United States to designate January 22 as «Ukrainian lndependence Day». January 22 was proclaimed Ukrainian Day by the governors of fifteen States and mayors of many cities. Keywords: January 22, Ukrainian independence day, Ukrainian diaspora, USA, interaction, Congress

TTIP, CETA, and TiSA Behind Closed Doors

2017 ◽  
Author(s):  
Panagiotis Delimatsis
Keyword(s):  
European Union ◽  
Global Governance ◽  
Early Stage ◽  
European Parliament ◽  
Trade Negotiations ◽  
The European Union ◽  
The Us ◽  
The Eu

Secrecy and informality rather than transparency traditionally reign trade negotiations at the bilateral, regional, and multilateral levels. Yet, transparency ranks among the most basic desiderata in the grammar of global governance and has been regarded as positively related to legitimacy. In the EU’s case, transparent trade diplomacy is quintessential for constitutional—but also for broader political—reasons. First, even if trade matters fall within the EU’s exclusive competence, the EU executive is bound by the Treaty on the Functioning of the European Union (TFEU) to inform the European Parliament, the EU co-legislator, in regular intervals. Second, transparency at an early stage is important to address public reluctance, suspicion, or even opposition regarding a particular trade deal. This chapter chronicles the quest for and turning moments relating to transparency during the EU trade negotiations with Canada (CETA); the US (TTIP), and various WTO members on services (TiSA).

scholarly journals Trends in educational mobility: How does China compare to Europe and the United States?

2019 ◽  
Vol 5 (2) ◽  
pp. 214-240
Author(s):  
Rob J Gruijters ◽  
Tak Wing Chan ◽  
John Ermisch
Keyword(s):  
Educational Opportunity ◽  
The United States ◽  
International Standards ◽  
Educational Mobility ◽  
The Us ◽  
The Usa ◽  
Economic Boom ◽  
The Uk ◽  
Large Decline ◽  
Inequality Of Educational Opportunity

Despite an impressive rise in school enrolment rates over the past few decades, there are concerns about growing inequality of educational opportunity in China. In this article, we examine the level and trend of educational mobility in China, and compare them to the situation in Germany, the Netherlands, the UK and the USA. Educational mobility is defined as the association between parents’ and children’s educational attainment. We show that China’s economic boom has been accompanied by a large decline in relative educational mobility chances, as measured by odds ratios. To elaborate, relative rates of educational mobility in China were, by international standards, quite high for those who grew up under state socialism. For the most recent cohorts, however, educational mobility rates have dropped to levels that are comparable to those of European countries, although they are still higher than the US level.

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