scholarly journals Biosimilars: Are They Ready for Primetime in the United States?

2011 ◽  
Vol 9 (8) ◽  
pp. 934-943 ◽  
Author(s):  
Bradford R. Hirsch ◽  
Gary H. Lyman
Keyword(s):  
United States ◽  
The United States ◽  
Pharmacokinetic Parameters ◽  
The European Union ◽  
Approval Process ◽  
Regulatory Pathway ◽  
Regulatory Requirements ◽  
Economic Implications ◽  
Ensure Patient Safety ◽  
Critical Issues

The introduction of alternative versions of biologic products, also known as biosimilars, into the United States market has been gaining increasing visibility as patents for many agents are nearing expiration. Unlike generics, which are regulated under the Hatch-Waxman legislation passed in 1984, the approval process for biosimilars in the United States has not been defined. In 2004, the European Union established a regulatory pathway for these agents, and the FDA is now following suit. The economic implications are large, with $66.9 billion spent on the top 20 biologics in 2009. Of the top 10 biologics, 6 are routinely used in oncology. As the regulatory requirements are debated, several critical issues must be resolved. The most obvious is that the agents must be shown to be comparable to the original biologic they intend to replace. Knowledge of pharmacokinetic parameters alone will not be adequate, but the amount of clinical data required by the FDA remains unclear. The regulations will define the ease with which a biosimilar can be brought to market, and the associated costs of trials will influence the ultimate price of the medications. Balancing the needs of the relevant stakeholders is critical to ensure patient safety while controlling costs, improving access, and encouraging innovation. This is not an easy balance to strike.

scholarly journals The analysis of approaches to conducting bioequivalence studies and the policy of “transparency” of their results in Ukraine, the United States and the European Union

2021 ◽  
Vol 25 (1) ◽  
pp. 32-40
Author(s):  
О.S. Popov ◽  
І.V. Kravchenko ◽  
V.Ye. Dоbrоvа ◽  
K.M. Tkachenko
Keyword(s):  
United States ◽  
European Union ◽  
Generic Drugs ◽  
Low Cost ◽  
The United States ◽  
The European Union ◽  
Regulatory Requirements ◽  
Drug Registration ◽  
Pharmaceutical Manufacturers ◽  
Mandatory Requirement

Providing the population of Ukraine with quality, effective and, at the same time, economically affordable medicines is a priority task of the healthcare system. Taking into account the relatively low cost of their development generic drugs are available to the majority of the country’s population; thus, bioequivalence studies are needed to obtain data on their efficacy and safety. Ukraine is currently in the process of harmonizing domestic regulatory requirements for generic drugs and conducting bioequivalence studies with global ones. Therefore, it is important to find out the differences in approaches to the registration of generics and studies of their bioequivalence in Ukraine and other countries. Another important aspect is to provide the policy of “transparency” of bioequivalence research results, which contributes to the use of better drugs. Aim. To analyze domestic and global approaches to the organization of the bioequivalence research and provide the policy of “transparency” of their results. Materials and methods. A comparative analysis of approaches to drug registration, requirements for generic drugs and bioequivalence studies and ways to provide the policy of “transparency” of their results in Ukraine, the United States and the European Union was conducted. Results. The analysis has revealed that the methods of registration of drugs in Ukraine, the United States and the EU are the same. Approaches to providing the “transparency” of the results of bioequivalence studies differ since in Ukraine the publication of such information is not mandatory and is at the discretion of pharmaceutical manufacturers. Conclusions. Domestic regulatory requirements for assessing generic drugs are harmonized with the world ones. Today, there is a need to introduce a mandatory requirement for the publication of bioequivalence studies, and it will contribute to providing an effective “transparency” policy.

For Your Eyes-Only: United States Internet Privacy Laws Play Catch-Up With The European Union Data Directive

2011 ◽  
Vol 1 (2) ◽  
Author(s):  
Peter L. Banfe ◽  
Dexter R. Woods
Keyword(s):  
United States ◽  
European Union ◽  
Self Regulation ◽  
Personal Data ◽  
The United States ◽  
Current Approach ◽  
The European Union ◽  
Internet Privacy ◽  
Critical Issues ◽  
European Union Data

Global electronic commerce, driven by the development of the Internet, promises to be a key engine of growth in this century. One of the most contentious issues facing businesses today is the ownership and use of personal data. Europe has taken the lead in this area with a comprehensive approach, the European Union Data Directive, that became effective in 1998. This paper compares the European Union approach to Internet privacy with that of the United States. In comparing the two, the paper includes a brief discussion of current legislation under both approaches and also discusses critical issues in the debate for Internet privacy, including state-directed legislation vs. self-regulation, corporate privacy statements, and the opt-in versus opt-out approaches to consumer protection. The paper offers perspectives on whether the United States will adopt new Internet privacy legislation, and on the feasibility and repercussions of maintaining the current approach.

scholarly journals A phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX04 to reference bevacizumab sourced from the United States, the European Union, and China in healthy Chinese male volunteers

2021 ◽  
Author(s):  
Xiaoxue Zhu ◽  
Hongjie Qian ◽  
Jixuan Sun ◽  
Min Wu ◽  
Chen Yu ◽  
...  
Keyword(s):  
United States ◽  
European Union ◽  
Phase 1 ◽  
The United States ◽  
Pharmacokinetic Parameters ◽  
Serum Drug Concentration ◽  
The European Union ◽  
Maximum Serum ◽  
Pharmacokinetic Profiles ◽  
Healthy Chinese

Abstract Purpose To compare the pharmacokinetic profiles, safety and immunogenicity of proposed bevacizumab biosimilar HLX04 with reference bevacizumab in healthy Chinese males. Methods In this double-blind Phase 1 study, healthy volunteers (N = 208) were randomized 1:1:1:1 to a single 3 mg/kg intravenous infusion of HLX04 or reference bevacizumab sourced from the United States (bevacizumab-US), the European Union (bevacizumab-EU) or China (bevacizumab-CN). Co-primary endpoints were area under the serum concentration–time profile (AUC) from time zero extrapolated to infinity (AUC0–inf) and from zero to last quantifiable concentration (AUClast). Secondary endpoint was the maximum serum drug concentration (Cmax). Study participants were monitored for treatment-emergent adverse events (TEAEs) and samples were collected for anti-drug antibody (ADA) testing throughout the study. Results Pharmacokinetic parameters were similar across groups. The respective geometric least-squares mean ratios (GLSMR) of AUC0–inf, AUClast and Cmax were: 95.7%, 96.0% and 101.8% for HLX04 versus bevacizumab-US; 94.3%, 94.6% and 100.5% for HLX04 versus bevacizumab-EU; and 90.0%, 90.4% and 98.2% for HLX04 versus bevacizumab-CN. For all test-to-reference comparisons, two-sided 90% confidence intervals of GLSMR for AUC0–inf, AUClast and Cmax fell in the pre-specified bioequivalence range (80–125%). There were no notable differences in the frequency, nature and/or grade of TEAEs. No deaths were reported and no ADAs were detected during the study. Conclusion HLX04 had similar safety and pharmacokinetic profiles to reference bevacizumab in healthy Chinese males, supporting the confirmatory Phase 3 study investigating the efficacy and safety equivalence between HLX04 and bevacizumab in patients with metastatic colorectal cancer (NCT03511963). Clinical trial registration The study was registered with Clinicaltrials.gov, NCT03483649.

A Comparative Evaluation of Licensing Requirements for Dry Storage of Spent Nuclear Fuel in the United States, Germany, Canada and the Russian Federation

2004 ◽  
Author(s):  
Edward Wonder ◽  
David S. Duncan ◽  
Eric A. Howden
Keyword(s):  
United States ◽  
Nuclear Fuel ◽  
Spent Nuclear Fuel ◽  
The United States ◽  
Approval Process ◽  
Spent Fuel ◽  
Regulatory Requirements ◽  
Fuel Storage ◽  
The Russian Federation ◽  
The Republic

Technical activities to support licensing of dry spent nuclear fuel storage facilities are complex, with policy and regulatory requirements often being influenced by politics. Moreover, the process is often convoluted, with numerous and diverse stakeholders making the licensing activity a difficult exercise in consensus-reaching. The objective of this evaluation is to present alternatives to assist the Republic of Kazakhstan (RK) in developing a licensing approach for a planned Dry Spent Fuel Storage Facility. Because the RK lacks experience in licensing a facility of this type, there is considerable interest in knowing more about the approval process in other countries so that an effective, non-redundant method of licensing can be established. This evaluation is limited to a comparison of approaches from the United States, Germany, Russia, and Canada. For each country considered, the following areas were addressed: siting; fuel handling and cask loading; dry fuel storage; and transportation of spent fuel. The regulatory requirements for each phase of the process are presented, and a licensing approach that would best serve the RK is recommended.

Russian Federation and the United States of America: geostrategic directions to manage the Ukrainian crisis

2019 ◽  
pp. 123
Author(s):  
Attarid Awadh Abdulhameed
Keyword(s):  
United States ◽  
European Union ◽  
National Security ◽  
Russian Federation ◽  
United States Of America ◽  
The United States ◽  
The European Union ◽  
The Usa ◽  
Ukrainian Crisis ◽  
Zero Sum

Ukrainia Remains of huge importance to Russian Strategy because of its Strategic importance. For being a privileged Postion in new Eurasia, without its existence there would be no logical resons for eastward Expansion by European Powers.  As well as in Connection with the progress of Ukrainian is no less important for the USA (VSD, NDI, CIA, or pentagon) and the European Union with all organs, and this is announced by John Kerry. There has always ben Russian Fear and Fear of any move by NATO or USA in the area that it poses a threat to  Russians national Security and its independent role and in funence  on its forces especially the Navy Forces. There for, the Crisis manyement was not Zero sum game, there are gains and offset losses, but Russia does not accept this and want a Zero Sun game because the USA. And European exteance is a Foot hold in Regin Which Russian sees as a threat to its national security and want to monopolize control in the strategic Qirim.

COMPARATIVE ANALYSIS OF THE CURRENT FRENCH FOREIGN POLICY ACTIVITY

2019 ◽  
Vol 22 (2) ◽  
pp. 74-79
Author(s):  
Nargiza Sodikova ◽  
◽  
◽  
Keyword(s):  
United States ◽  
European Union ◽  
Foreign Policy ◽  
International Security ◽  
The United States ◽  
Foreign Affairs ◽  
Modern Time ◽  
The European Union ◽  
National Interests ◽  
French Foreign Policy

Important aspects of French foreign policy and national interests in the modern time,France's position in international security and the specifics of foreign affairs with the United States and the European Union are revealed in this article

Ocena antykryzysowej polityki gospodarczej Stanów Zjednoczonych i wybranych państw członkowskich Unii Europejskiej w latach 2005–2014

2016 ◽  
pp. 26-46
Author(s):  
Marcin Jan Flotyński
Keyword(s):  
United States ◽  
European Union ◽  
Financial Markets ◽  
Global Economy ◽  
Global Financial Crisis ◽  
The United States ◽  
The European Union ◽  
High Volatility ◽  
The Global Financial Crisis ◽  
Domestic Products

The global financial crisis in 2007–2009 began a period of high volatility on the financial markets. Specifically, it caused an increased amplitude of fluctuations of the level of gross domestic products, the level of investment and consumption and exchange rates in particular countries. To address the adverse market circumstances, governments and central banks took actions in order to bolster the weakening global economy. The aim of this article is to present the anti-crisis actions in the United States and selected member states of the European Union, including Poland, and an assessment of their efficiency. The analysis conducted indicates that generally the actions taken in the United States in response to the crisis were faster and more adequate to the existing circumstances than in the European Union.

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