Imitation and innovation new biologics,biosimilars and biobetters

ABSTRACT

Biopharmaceutical drugs are the future of the pharmaceutical industry. The United States is the world leader in the development of new biopharmaceutical products. These original new drugs, numbering close to 200, are now losing patent protection and imitators from several countries are entering the markets of comparable drugs, called biosimilars. Some companies are improving the original product, and these drugs are called biobetters. Even among the producers of biosimilars one finds different strategies, and these are linked to different government regulations concerning the approval of these products. Some biosimilar companies are aiming at developed-country markets (North America, the European Union and Japan), while other producers are targeting emerging, less-regulated markets. This introduction will present the dynamic picture of an industry in transition. The paper has a double aim: discuss the fuzzy frontier between imitation and innovation, and track the new contours of the pharmaceutical industry.     

美国技术政策新动向浅析

近年来,面对中国高技术产业的快速发展和竞争,美国一改以往任由技术与产业自由发展的政策,开始加大对其的干预和支持力度。本文首先梳理了美国技术政策的发展与演变,其次通过分析美国联邦政府的举措、美国国会的立法提案以及美国智库的观点,对美国近年来的技术政策动向进行了研判,最后针对我国如何应对提出了几点思考。     

美国可再生能源政策研究

美国政府从20世纪70年代开始重视可再生能源,但是,由于可再生能源初期运营成本高,风险大,其低排放与可循环等优势不能体现在价格上,因此,与传统能源相比没有竞争优势.为此,美国联邦政府相继出台了一系列的法律、法规,地方政府也制定了配套的经济激励政策,从而促进可再生能源在美国的推广应用和产业发展.本文介绍了美国联邦政府及地方政府在可再生能源方面的有关政策,希望对我国有所启示.     

A cost-effectiveness analysis comparing the originator follitropin alfa to its biosimilars in patients undergoing a medically assisted reproduction program from a French perspective

Objective: To assess the cost-effectiveness (CE) of the originator follitropin-α (Gonal-F) in patients undergoing a medically assisted reproduction (MAR) program in comparison to its biosimilars Bemfola and Ovaleap in a French context.

Methods: A CE model was developed for France with a National Health Service (NHS) perspective. Clinical, safety, and dosage data were derived from pivotal clinical trials that compared Gonal-F to Ovaleap and Bemfola. Costs pertaining to drugs, hospitalizations, specialist visits, and examinations were retrieved from the French Programme de Médicalisation des Systèmes d'Information (PMSI) hospital database, literature review, and French clinical experts using 2017?Euro tariffs. In order to test the robustness of results, deterministic one-way sensitivity analyses were carried out on the main variables to assess the impact of treatment cost, probability of birth, ovarian hyperstimulation syndrome (OHSS) rates, and dosage.

Results: The average incremental cost per live birth with OHSS and without OHSS was €259.56 and €278.39, respectively, for Gonal-F compared to the pooled biosimilars (i.e. Ovaleap and Bemfola). GONAL-F had an incremental efficacy of 0.06 over the pooled biosimilars. The incremental cost-effectiveness ratio for Gonal-F with OHSS ranged from €3,274.80 to €4,877.76 compared to the pooled biosimilars, owing to the additional live births reported with Gonal-F. Sensitivity analyses also supported results from the base case analyses, with Gonal-F being cost-effective or the dominant strategy in most cases.

Conclusion: Gonal-F seems to be a cost-effective strategy compared to its biosimilars Ovaleap and Bemfola, irrespective of the incidence of OHSS events, but further data are needed to confirm these results.     

基于专利信息的中美区块链技术竞争态势分析

当前区块链技术仍处于快速发展期,对中美整体竞争格局影响至关重要。专利是关键技术的代表、产业发展的基石,从专利信息出发,可以把握技术竞争态势,进而管窥中美区块链产业发展差异,为我国区块链产业发展提供政策建议。基于德温特专利数据,采取专利分析法和社会网络分析法对其进行深度挖掘,结合“新钻石模型,研究发现,在政府、机会、需求条件、知识吸收层面上,中国区块链技术及产业具有优势地位;而在生产要素、产业支持、企业战略结构与创新能力方面,美国优势更为明显。从政府、行业、企业层面分别提出建议：①政府层面,继续保持在政府管理与公共服务领域的优势;②行业层面,注重提高区块链专利质量;③企业层面,提高国际合作能力,加强区块链服务于实体经济。     

The United States is a Small Country in World Trade*

Despite being the largest country in world trade and thus presumably having high optimal tariffs, the United States has long had low and declining levels of protection. This paradox suggests that the United States is failing to exploit its monopsony power by levying optimal tariffs. Using data on world output and trade flows, we find that the United States is a small country in world trade in that its trade policies have negligible impacts on world prices. In the median manufacturing industry, US tariffs reduce world prices by only 0.12%. United States optimal tariffs are also typically small (3.6% in the median industry) and are lower than existing US tariffs in most industries. It is no puzzle that the United States has been a champion of free trade since the 1930s—the United States, like other small countries, benefits economically from tariff reductions.     

WILLINGNESS TO PAY FOR SURPLUS SUGAR IN THE UNITED STATES

Sugar supply is managed in the United States to support minimum prices set by law. The 2008 farm bill contains the sugar‐to‐ethanol program to sell surplus sugar to ethanol producers and a program that allows bids from sugar processors. The sugar program is required to run at no net cost to taxpayers. Bids for surplus sugar are analyzed under various scenarios. Sugar processors will outbid ethanol producers given current ethanol prices. At present, surplus sugar bids will not exceed the minimum prices, and the sugar‐to‐ethanol program will not be able to help the government achieve no net program costs. (JEL Q18, Q42, Q48)     

Comparing olanzapine and ziprasidone in the treatment of schizophrenia: a case study in modeling

SUMMARY

When a new drug is introduced to the market, the availability of head-to-head data for comparisons of annual cost and health outcomes with other drugs already on the market is usually insufficient. When only limited head-to-head data are available, one alternative is to perform preliminary modeling using data from the best available studies. In this paper, we synthesise data from the most comparable available studies to create a model to compare the annual costs and health outcomes when initiating treatment for schizophrenia with one of two antipsychotic drugs: olanzapine, which was launched in the United States (US) market in September 1996, and ziprasidone, which was approved by the US Food and Drug Administration (FDA) in February 2001. Annual treatment costs were determined by response and relapse rates as well as acquisition costs. The results indicate similar annual treatment costs (US$48,676 for olanzapine; US$48,873 for ziprasidone), despite the lower drug acquisition cost for ziprasidone. Annual health outcomes differed between the olanzapine and ziprasidone groups with 23.5% and 25.2% relapsed, 36.7 and 37.4 hospital days, and 60.0 and 60.1 EPS days in the olanzapine and ziprasidone groups respectively. A head-to-head naturalistic trial is needed to validate the results of this modeling exercise.     

Federal homelessness policy: A robust political economy approach

In the wake of the financial crisis, the United States government introduced a new large-scale initiative to address homelessness. The policy mandate is marked by both an unprecedented increase in federal funding and a dramatic reallocation of resources toward Housing First, a service model emphasizing immediate housing subsidization. Although this service paradigm has received support from a sizeable literature, our knowledge of its success to date has been limited. This paper sheds light on the unobservable or unmeasured costs of this new centralized approach to ending homelessness. I argue that federal homelessness policy under the Housing First approach 1) generates resource misallocation, 2) exacerbates the Samaritan’s dilemma, and 3) invites rent seeking.     

美国地方行政区划若干问题探讨

本文在正确认识美国联邦政府和州政府之间的关系基础上．着重对美国的地方行政区划、地方行政区划单位和地方行政区划的特点进行了论述．进而讨论了美国联邦政府—州政府—地方政府之间的相互关系以及州政府之间的关系．形成了对美国地方行政区划的一些比较正确的认识。     

Psychological War in Vietnam: Governmentality at The United States Information Agency

ABSTRACT

The United States Information Agency (USIA) has received little sustained scrutiny from critical military geographers, despite the major role it played in waging the Cold War. This article outlines the USIA’s role in waging psychological war in support of the US mission in Vietnam, notably its establishment in 1965 of the Joint United States Public Affairs Office (JUSPAO). Through an analysis of USIA operations, this article argues that psychological war can be understood as a governmental strategy to exert power over the people and territory of Vietnam. Through an examination of problems related to evaluating and conducting research for psychological war, this article questions the extent to which the United States succeeded in establishing this power, concluding that the effects of psychological war in Vietnam were, at best, inconclusive, and offer little evidence to support contemporary strategies to ‘win hearts and minds’.     

The Impact of Treasury Yields on US Presidential Approval, 1960–2010

ABSTRACT

The ‘power of bond markets’ is a widely assumed and poorly understood feature of the global economy. We demonstrate that even in a bond market as stable as the United States this influence is considerable. In this article, we scrutinise a particularly direct influence, the impact of US Treasury yields on presidential approval rates. Our empirical analysis from 1961 to 2010 demonstrates that rising/falling bond yields lead to a decline/increase in approval rates. We show that this impact is mediated via the US mortgage market. The stronger the rise in mortgage rates, the stronger the influence of Treasury yields on presidential approval. We then outline the broader possible political impacts of this, particularly given foreign and domestic central bank ownership of US Treasuries.     

Support of State and Local Finance under Persistent Federal Deficits

The United States?? federal government subsidizes local public finance through grants. Given projected U.S. deficits, this may prove untenable. Further, a broader range of policy instruments may offer more effective support of local governments. Herein four policies are considered beginning with current policy: federal deficit financed grants, federal placement, federal underwriting, and Federal Reserve System interventions. Options are evaluated in a general framework considering citizen and government objective functions. Policy recommendations are for interventions to specify terms of entry and exit (as with automatic stabilizers), and for initiation of contingency-simulation exercises to determine the potential of options identified herein.     

Institutional Adjustment,Instrumental Efficiency,and Reasonable Value

Abstract:

In this paper, we apply Celso Furtado’s vision of the process of economic development to the United States’ economy. Furtado was a creator of Latin American structuralism and continues to be one of the region’s most influential economists. Yet, he is little known in the English literature. As we argue, there are few academics who offer a theoretical framework capable of robustly evaluating the current trajectory of U.S. economic development with the depth of Furtado. Through his analytical lens, and with some help from John Maynard Keynes, we examine the present reality, as well as the more remote economic history of the US. We argue that, seen through Furtado’s lens, the US can now be accurately described as an under-developing economy.     

US Fiscal Policy,Manufacturing Stagnation,and the Shift to Financialization in the Era of Globalization: An Econometric Analysis, 1973–2015

ABSTRACT

Financialization can be partially attributed to the decline in the US manufacturing profit rate since the 1970s. However, scholars have not reached a consensus regarding the factors responsible for stagnation in manufacturing. This paper employs an Auto-regressive Distributed Lag (ARDL) model to test the impact of both national defense and government consumption expenditure on manufacturing profitability in the United States from 1973, the onset of stagnation, to 2015. Its goal is two-fold: to determine whether stagnation is associated with a decline in Keynesian policies, and to examine the potential for state fiscal programs to reverse this trend and facilitate a shift of private investment away from the financial sector and into manufacturing. The paper finds that the impact of government consumption expenditure on the manufacturing profit rate is positive and significant in both the short-term and long-term (from 1973–2015 and 1973–1993), while the long-term impact becomes negative from 1983 to 2015, when the financial sector profit rate began its upward trend. This casts doubt on whether Keynesian fiscal policies could be employed to restore a healthy profit rate in the manufacturing sector and lower unemployment.     

Is Beta-t-EGARCH(1,1) superior to GARCH(1,1)?

Statistical performance, in-sample point forecast precision and out-of-sample density forecast precision of GARCH(1,1) and Beta-t-EGARCH(1,1) models are compared. We study the volatility of nine global industry indices for period from April 2006 to July 2010. Competing models are estimated for periods before, during and after the United States (US) financial crisis of 2008. The results provide evidence of the superior out-of-sample predictive performance of Beta-t-EGARCH compared to GARCH after the US financial crisis.     

Incentive effects of benevolent intervention: The case of government loan guarantees

There has been a substantial recent growth in government loan guarantees to ailing firms in the United States. This paper investigates the potential incentive effects of this practice. Using the simplest available two-period model, it is shown that when firms know that loan guarantees may be forthcoming, they may be induced to adopt riskier investments and take on more leverage. These perverse incentive effects imply that the actual loan-guarantees-related contingent liability of the government could be much larger than suspected. Our policy recommendation is that the government either abandon the practice altogether or set up a federal agency that sells loan guarantees to all firms at prices that depend on the riskiness of the firm's assets and its leverage.     

Cost estimate of platelet transfusion in the United States for patients with chronic liver disease and associated thrombocytopenia undergoing elective procedures

Aims: This study aimed to estimate the cost of platelet transfusion in patients with chronic liver disease (CLD)-associated thrombocytopenia undergoing an elective procedure in the United States.

Materials and methods: The study was conducted in two parts: development of a conceptual framework identifying direct, indirect and intangible costs of platelet transfusion, followed by the estimation of the total cost of platelet transfusion in patients with CLD-associated thrombocytopenia before an elective procedure in the United States using the conceptual framework and cost data obtained from a literature search. The cost of the entire care required to raise a patient’s platelet count before the procedure was considered.

Results: The final conceptual framework included the costs of generating the supply of platelets, the platelet transfusion itself, adverse events associated with platelet transfusion and refractoriness to platelet transfusion. When costs were accounted for in all the framework cost categories, the total direct cost of a platelet transfusion in a patient with CLD and associated thrombocytopenia was estimated to be in the range of $5258 to $13,117 (2017?US dollars) in the United States. The largest portion of costs was incurred by the transfusion event itself ($3723 to $4436) and the cost of refractoriness ($874 to $7578), which included the opportunity cost of a delayed procedure and subsequent platelet transfusions with human leukocyte antigen-matched platelets.

Limitations and conclusions: Although we were unable to include all cost components identified in the conceptual framework in our total cost estimate, thus likely underestimating the true total cost, and despite the data gaps and challenges limiting our estimate of the full cost of a platelet transfusion in patients with CLD-associated thrombocytopenia undergoing an elective procedure in the United States, this study outlines a comprehensive conceptual framework for estimating the cost elements of a platelet transfusion in these patients.     

Foresight analysis of tilapia supply chains (Sistema Producto) in four states in Mexico: Scenarios and strategies for 2018

In order to increase competitiveness among individual producers and to encourage their integration, the federal government of Mexico has pursued the establishment, at both the state and national levels, of supply chains, or Sistema Producto (SP). For fisheries and aquaculture, 33 SPs exist at the state level and 7 at the national level, 1 of them for tilapia. The objective of this study is to carry out a foresight analysis (FA) of 4 tilapia SPs in Mexico—for the States of Colima, Sonora, Tabasco and Yucatán—analyzing their 2018 vision for the development of the tilapia chain. FA provides an integral vision of both the internal and external environments, identifying the key factors for each SP and helping to develop the best strategies in order to compete successfully. Sonora, Tabasco and Yucatán identify marketing aspects as key elements for their 10-year future: adding value to the product by means of new processing technologies, developing their own brand, and identifying and differentiating their product based on sanitary issues. Colima focuses its industry future success on efficiency improvements. Finally, the main technological disruptions identified by the 4 states are the incremental use of information technology, product and process certification, new hatcheries with genetically-improved fry, and new processing methodologies developed and/or applied.     

(Not) Valuing Care: A Review of Recent Popular Economic Reports on Preschool in the US

Abstract

Recently, a series of popular economics “Invest in Kids” (IIK) reports in the United States has called for increased investment in children's early education. These national reports articulate a new concept, the “public finance value” of children, and argue for increased investment in preschool because of its positive impact on the long-term fiscal health of the nation. This paper analyzes the IIK reports from 2003–6 to assess their attention to the multidimensional aspects of early care and education (ECE) in the US. Although the reports evaluate increased investment in preschool, they fail to recognize the need for a comprehensive system of ECE that includes support for childcare and the unpaid care and education provided by parents. As a result, the reports undervalue the contributions of women and of the ECE sector itself. Feminist economics offers a broader perspective that would help the IIK authors avoid conceptual traps and recognize the need for more comprehensive reforms.