Recognizing barriers to entry of biosimilars in the United States market and highlighting the solutions

2020 ◽  
pp. 174113432097215
Author(s):  
Arpit Bana ◽  
Priti J Mehta
Keyword(s):  
Patent Protection ◽  
Reference Product ◽  
Market Competition ◽  
The United States ◽  
Living Cells ◽  
Barriers To Entry ◽  
The Us ◽  
The Government ◽  
The Cost ◽  
The U.S

Drugs that are procured from living cells and are used to treat acute and chronic diseases are called biologics, whereas biosimilars are the drugs which are highly similar but not identical to the original reference product. The main advantage of these drugs is that they are highly targeted with great therapeutic activity and can be used for multiple indications. Despite all the advantages biologics are still extremely costly. The main purpose of developing and introducing biosimilars was and is to increase market competition leading to a decrease in the cost of the biologics. However, until now the cost of the treatment has not decreased in the US market because there are many barriers to the entry of biosimilar in the US market which are discussed in this article. In this article, we argue that the barrier or hurdle in the US market entry of the biosimilars is not only limited to patent protection or exclusivity but other less discussed barriers are also there which are to be discussed. Due to these barriers till June 10, 2020, only 9 biosimilars are available commercially in the US market out of the 27 biosimilars approved for marketing by the U.S. Food and Drug Administration (FDA). We argue that the introduction of these biosimilars in the US market is essential for increasing market competition and thus decreasing the overall treatment cost for both the government and the payers. In this article, we are also providing perspective on the possible solutions to reduce these barriers and to encourage the entry of biosimilar in the US market.

Palestine Unbound

2018 ◽  
Vol 47 (3) ◽  
pp. 130-134
Keyword(s):  
United States ◽  
Human Rights ◽  
Task Force ◽  
The United States ◽  
Donald Trump ◽  
Tel Aviv ◽  
The Us ◽  
Intention To Move ◽  
Arab Israeli Conflict ◽  
The U.S

This section, updated regularly on the blog Palestine Square, covers popular conversations related to the Palestinians and the Arab-Israeli conflict during the quarter 16 November 2017 to 15 February 2018: #JerusalemIstheCapitalofPalestine went viral after U.S. president Donald Trump recognized Jerusalem as the capital of Israel and announced his intention to move the U.S. embassy there from Tel Aviv. The arrest of Palestinian teenager Ahed Tamimi for slapping an Israeli soldier also prompted a viral campaign under the hashtag #FreeAhed. A smaller campaign protested the exclusion of Palestinian human rights from the agenda of the annual Creating Change conference organized by the US-based National LGBTQ Task Force in Washington. And, UNRWA publicized its emergency funding appeal, following the decision of the United States to slash funding to the organization, with the hashtag #DignityIsPriceless.

American and Canadian Civil Actions Alleging Human Rights Violations Abroad by Oil and Gas Companies

2008 ◽  
Vol 45 (3) ◽  
pp. 653 ◽  
Author(s):  
Jonathan Horlick ◽  
Joe Cyr ◽  
Scott Reynolds ◽  
Andrew Behrman
Keyword(s):  
Human Rights ◽  
Oil And Gas ◽  
The United States ◽  
Human Rights Violations ◽  
Law Of Nations ◽  
Forum Non Conveniens ◽  
The Government ◽  
Oil And Gas Companies ◽  
Political Question ◽  
The U.S

Under the United States Alien Tort Statute, which permits non-U.S. citizens to bring lawsuits in U.S. courts for human rights violations that are violations of the law of nations, plaintiffs have filed claims against multinational oil and gas corporations for the direct or complicit commission of such violations carried out by the government of the country in which the corporation operated. In addition to exercising jurisdiction over U.S. corporations, U.S. courts have exercised jurisdiction in cases involving non-U.S. defendants for alleged wrongful conduct against non-U.S. plaintiffs committed outside the U.S.The exercise of jurisdiction by U.S. courts over non-U.S. defendants for alleged wrongful conduct against non-U.S. plaintiffs committed outside of the U.S. raises serious questions as to the jurisdictional foundation on which the power of U.S. courts to adjudicate them rests. Defences that foreign defendants can raise against the exercise of jurisdiction by the U.S. courts are an objection to the extraterritorial assertion of jurisdiction, the act of state doctrine, the political question doctrine, forum non conveniens, and the principle of comity. These defences are bolstered by the support of the defendant’s home government and other governments.

Abstract P183: 20-year Secular Trend of Cardiovascular Disease Comorbidities in the United States, 1997-2016

Circulation ◽  
2018 ◽  
Vol 137 (suppl_1) ◽  
Author(s):  
Dianjianyi Sun ◽  
Tao Zhou ◽  
Xiang Li ◽  
Yoriko Heianza ◽  
Xiaoyun Shang ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Secular Trend ◽  
Adult Population ◽  
The United States ◽  
The Past ◽  
The Us ◽  
Metabolic Conditions ◽  
Respiratory Conditions ◽  
The U.S ◽  
Chronic Comorbidities

Background: Cardiovascular disease (CVD) has been the number one cause of death and disability in the US and globally for decades, and its comorbidity complicates the management of CVD. However, little is known about the secular trend of CVD comorbidities in national representative populations in the last 20 years. Methods: Prevalence of CVD and nine major chronic comorbidities was estimated using data from 1,324,214 adults aged 18 years and older in the National Health Interview Survey (NHIS) from 1997 through 2016, with age-standardized to the U.S. population in the year 2000. Results: CVD prevalence in the US adult population significantly declined in the past twenty years (from 6.6% in 1997 to 5.9% in 2016, P trend <0.01in Figure a). And such trend was shown in women and whites (P trend <0.01), but not in men and blacks (P trend >0.05). We ranked the nine major chronic comorbidities (high to low) in the CVD patients (Figure b.), including (1) hypertension, (2) respiratory conditions, (3) nervous system conditions, (4) digestive conditions, (5) diabetes, (6) cancer, (7) genitourinary conditions, (8) circulatory conditions, and (9) endocrine/nutritional/metabolic conditions. From 1997 to 2016, the prevalence of CVD comorbidities including hypertension (38.8% to 50.2%), digestive conditions (17.0% to 27.1%), diabetes (10.0% to 19.2%), cancer (9.4% to 12.8%), and genitourinary conditions (4.1% to 5.2%) continuingly increased (all P trend <0.01), while respiratory conditions declined (35.9% to 27.6%, P trend <0.01). Similar trends of CVD comorbidities were observed among subgroups stratified by gender or by race. Conclusions: CVD prevalence in the U.S. adults have declined significantly in the past two decades, but rates of CVD comorbidities including hypertension, digestive conditions, diabetes, cancer, and genitourinary conditions increased substantially.

Impact of Government Bailout on Banks’ Cost of Equity: Additional Evidence from the Financial Bailout of 2008–2009

2021 ◽  
Vol 24 (01) ◽  
pp. 2150003
Author(s):  
Daphne Wang ◽  
Robert Houmes ◽  
Thanh Ngo ◽  
Omar Esqueda
Keyword(s):  
Institutional Ownership ◽  
The United States ◽  
Matched Sample ◽  
Cost Of Equity ◽  
Troubled Asset Relief Program ◽  
Low Concentrations ◽  
The Government ◽  
The Cost ◽  
Relief Program ◽  
Robust Evidence

The Capital Purchase Program (CPP) was the first and most significant program under the Troubled Asset Relief Program (TARP) during 2008–2009 financial crisis. This study evaluates the effect of the CPP during this period on the cost of equity of 170 publicly listed banks in the United States that received funding. To control for the potential effects of endogeneity on our results, we use a propensity score matched sample of non-CPP banks. Using this approach, we document robust evidence that the liquidity provided by the government bailout reduced the cost of equity for recipient banks, especially for those banks that repaid their bailout funds in full. This decrease in the cost of equity is particularly significant for banks with high market-to-book ratios, low concentrations of institutional ownership, and those banks with at least one large blockholder. Our findings have important implications for the assessment of government bailout programs and the future regulation of financial institutions.

scholarly journals The comparison of vaccine hesitancy of COVID-19 vaccination in China and the United States

2021 ◽  
Author(s):  
Taoran Liu ◽  
Zonglin He ◽  
Jian Huang ◽  
Ni Yan ◽  
Qian Chen ◽  
...  
Keyword(s):  
United States ◽  
Propensity Score ◽  
Propensity Score Matching ◽  
Discrete Choice ◽  
Choice Experiments ◽  
The United States ◽  
Discrete Choice Experiments ◽  
Vaccine Hesitancy ◽  
The Us ◽  
The Cost

AbstractObjectivesTo investigate the differences in vaccine hesitancy and preference of the currently available COVID-19 vaccines between two countries, viz. China and the United States (US).MethodA cross-national survey was conducted in both China and the US, and discrete choice experiments as well as Likert scales were utilized to assess vaccine preference and the underlying factors contributing to the vaccination acceptance. A propensity score matching (PSM) was performed to enable a direct comparison between the two countries.ResultsA total of 9,077 (5,375 and 3,702, respectively, from China and the US) respondents have completed the survey. After propensity score matching, over 82.0% respondents from China positively accept the COVID-19 vaccination, while 72.2% respondents form the US positively accept it. Specifically, only 31.9% of Chinese respondents were recommended by a doctor to have COVID-19 vaccination, while more than half of the US respondents were recommended by a doctor (50.2%), local health board (59.4%), or friends and families (64.8%). The discrete choice experiments revealed that respondents from the US attached the greatest importance to the efficacy of COVID-19 vaccines (44.41%), followed by the cost of vaccination (29.57%), whereas those from China held a different viewpoint that the cost of vaccination covers the largest proportion in their trade-off (30.66%), and efficacy ranked as the second most important attribute (26.34%). Also, respondents from China tend to concerned much more about the adverse effect of vaccination (19.68% vs 6.12%) and have lower perceived severity of being infected with COVID-19.ConclusionWhile the overall acceptance and hesitancy of COVID-19 vaccination in both countries are high, underpinned distinctions between countries are observed. Owing to the differences in COVID-19 incidence rates, cultural backgrounds, and the availability of specific COVID-19 vaccines in two countries, the vaccine rollout strategies should be nation-dependent.

scholarly journals On the ethics of doctors in capitalist countries

1981 ◽  
Vol 62 (5) ◽  
pp. 80-83
Author(s):  
S. Ya. Chikin
Keyword(s):  
United States ◽  
Surgical Intervention ◽  
The United States ◽  
For Profit ◽  
Us Congress ◽  
The Us ◽  
The Cost

In 1977, the US Congress published statistics on the operation of surgical clinics in many cities in the country. These materials cannot be read without a shudder. They once again proved that American doctors are no different from businessmen in their passion for profit. The report's conclusion was very sad. He testified that up to three million unjustified surgeries are performed annually in the United States. Naturally, they are not undertaken for the sake of the patient's health, but in order to present a more weighty bill to the patient, because the cost of the simplest surgical intervention is now estimated at at least $ 1000.

scholarly journals The Future of Turkey - United States Relations

Jurnal ICMES ◽  
2018 ◽  
Vol 2 (2) ◽  
pp. 179-196
Author(s):  
Firmanda Taufiq
Keyword(s):  
United States ◽  
The United States ◽  
Economic Interests ◽  
The Us ◽  
The Future ◽  
Foreign Policies ◽  
The Government ◽  
The Cold War ◽  
Role Of The Government

Throughout 2018, relations between Turkey and the United States seemed to deteriorate. The leaders of the two countries issued sharp diplomatic statements and the US even imposed economic sanctions on Turkey. This article aims to analyze how the future of relations between Turkey and the United States. Cooperation between the two has a long historical side after the Cold War. Relations between the two countries are based on various interests, both economic, political, military and security interests. The theory used in this study is the theory of national interest. The US has great interests in the Middle East and Turkey is the front-line ally in achieving those interests. However, there are many US foreign policies that ignore the Turkish concern and create tensions between the two countries. On the contrary, Turkey also has considerable economic interests, but the role of the government elite (in this case, President Erdogan) has a significant influence in the determination of Turkish foreign policy. The findings of this study, although it will go through complex challenges and processes, the US and Turkey will continue to maintain their relations.

scholarly journals Warlords, the United States, and the state of anarchy in Afghanistan

2021 ◽  
Vol 6 (2) ◽  
Author(s):  
Ahmad Shah Azami
Keyword(s):  
United States ◽  
The United States ◽  
State Building ◽  
The State ◽  
Negative Consequences ◽  
Human Rights Abuses ◽  
Illegal Mining ◽  
The Us ◽  
The Government ◽  
The Impact

As part of its “War on Terror”, the United States (US) provided immense sums of money and advanced equipment to Afghan warlords in order to defeat and dismantle the Taliban and al-Qaeda in Afghanistan. Nearly two decades after the 2001 US-led intervention in Afghanistan that toppled the Taliban regime, the US continues supporting the warlords in various ways. As the intervention was also aimed at establishing a functioning state and reconstruction of the war-torn country, the US needed the support of local warlords to achieve its goals. However, over time, warlords and warlordism became a major challenge to the postTaliban state-building project and in many ways undermined the overall security and the state monopoly on violence. These warlords, who had been mostly expelled and defeated by the Taliban regime, returned under the aegis of the B52 bombers, recaptured parts of the country and reestablished their fiefdoms with US support and resources. They not only resist giving up the power and prestige they have accumulated over the past few years, but also hamper the effort to improve governance and enact necessary reforms in the country. In addition, many of them run their private militias and have been accused of serious human rights abuses as well as drug trafficking, arms smuggling, illegal mining and extortion in the areas under their control or influence. In many ways, they challenge the government authority and have become a major hurdle to the country’s emerging from lawlessness and anarchy. This paper explores the emergence and reemergence of warlords in Afghanistan as well as the evolution of chaos and anarchy in the country, especially after the US-led intervention of late 2001. It also analyzes the impact of the post-9/11 US support to Afghan warlords and its negative consequences for the overall stability and the US-led state-building process in Afghanistan.

scholarly journals MANDATORY DEATH PENALTY IN THE GLOBALIZED WORLD

2016 ◽  
pp. 0-0
Author(s):  
Ирина Нагорная ◽  
Irina Nagornaya
Keyword(s):  
Death Penalty ◽  
The United States ◽  
Global Trend ◽  
The Us ◽  
Us Supreme Court ◽  
The Subject ◽  
Points Of View ◽  
The Government ◽  
Globalized World ◽  
Further Development

The subject of this research is the death penalty as a mandatory punishment for the most serious crimes in the United States, Asia and the Caribbean and corresponding constitutional problems. The author analyses foreign courts’ judgments and foreign researchers’ points of view. The author considers the influence of the jurisprudence of the US Supreme Court on the countries with similar legal systems, the importance of legal thought in other countries for further development of law-enforcement practice in a particular region and the globalized world. The author analyzes inconsistent position of Singapore, as well as the indecisiveness of the government of Malaysia, because until recently these two countries were fervent supporters of the mandatory death penalty in the Commonwealth. The author supports the global trend towards the abolition of the mandatory death penalty and the fact that the “Asian values” are not an insurmountable barrier to achieve this goal.

A Review of DOE ECUT Tribology Surveys

1986 ◽  
Vol 108 (4) ◽  
pp. 497-501 ◽  
Author(s):  
L. S. Dake ◽  
J. A. Russell ◽  
D. C. Debrodt
Keyword(s):  
Friction And Wear ◽  
Surface Modifications ◽  
The United States ◽  
Department Of Energy ◽  
Energy Losses ◽  
Research Needs ◽  
Technology Program ◽  
Heat Engines ◽  
The Government ◽  
The U.S

Experts estimate that in 1978 over four quadrillion Btu of energy were lost in the United States because of simple friction and wear. The Energy Conversion and Utilization Technology Program (ECUT) in the U.S. Department of Energy commissioned six surveys from various experts in the field of tribology to learn about the causes of these energy losses and how to reduce them. The surveys included: 1) identification of typical tribology energy sinks in industry, 2) reduction of tribological losses in utilities and transportation, 3) tribological research needed for advanced heat engines, 4) energy conservation potential of new surface modifications, 5) identification of current tribology work sponsored by the government, and 6) an assessment of industrial research needs. A summary of the major findings of each survey is included in this paper.

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