scholarly journals The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA

Pharmaceutics ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 48
Author(s):  
Ioana Gherghescu ◽  
M. Begoña Delgado-Charro
Keyword(s):  
Drug Administration ◽  
Action Plan ◽  
European Medicines Agency ◽  
Patient Access ◽  
Clinical Evaluations ◽  
The Past ◽  
The Us ◽  
Improve Patient ◽  
The Eu

Biosimilar medicines expand the biotherapeutic market and improve patient access. This work looked into the landscape of the European and US biosimilar products, their regulatory authorization, market availability, and clinical evaluation undergone prior to the regulatory approval. European Medicines Agency (EMEA, currently EMA) and Food and Drug Administration (FDA) repositories were searched to identify all biosimilar medicines approved before December 2019. Adalimumab biosimilars, and particularly their clinical evaluations, were used as a case study. In the past 13 years, the EMA has received 65 marketing authorization applications for biosimilar medicines with 55 approved biosimilars available in the EU market. Since the first biosimilar approval in 2015, the FDA has granted 26 approvals for biosimilars with only 11 being currently on the US market. Five adalimumab biosimilars have been approved in the EU and commercialized as eight different medicines through duplicate marketing authorizations. Whilst three of these are FDA-approved, the first adalimumab biosimilar will not be marketed in the US until 2023 due to Humira’s exclusivity period. The EU biosimilar market has developed faster than its US counterpart, as the latter is probably challenged by a series of patents and exclusivity periods protecting the bio-originator medicines, an issue addressed by the US’s latest ‘Biosimilar Action Plan’.

scholarly journals European research on children’s internet use: Assessing the past and anticipating the future

2017 ◽  
Vol 20 (3) ◽  
pp. 1103-1122 ◽  
Author(s):  
Sonia Livingstone ◽  
Giovanna Mascheroni ◽  
Elisabeth Staksrud
Keyword(s):  
Internet Use ◽  
Action Plan ◽  
The Internet ◽  
Moral Panics ◽  
Policy Makers ◽  
Internet Studies ◽  
The Past ◽  
Evidence Review ◽  
The Eu

In this article, we reflect critically on the research agenda on children’s Internet use, framing our analysis using Wellman’s three ages of Internet studies and taking as our case study the three phases of research by the EU Kids Online network from 2006 to 2014. Following the heyday of moral panics, risk discourses and censorious policy-making that led to the European Commission’s first Internet Action Plan 1999–2002, EU Kids Online focused on conceptual clarification, evidence review and debunking of myths, thereby illustrating the value of systematic documentation and mapping, and grounding academic, public and policy-makers’ understanding of ‘the Internet’ in children’s lives. Consonant with Wellman’s third age, which emphasizes analysis and contextualization, the EU Kids Online model of children’s online risks and opportunities helps shift the agenda from how children engage with the Internet as a medium to how they engage with the world mediated by the Internet.

Prohibition, Legalization, and Political Consumerism

2018 ◽  
pp. 740-769 ◽  
Author(s):  
Elizabeth A. Bennett
Keyword(s):  
Social Movements ◽  
Legal Status ◽  
Ethical Issues ◽  
Drug Control ◽  
Psychoactive Substance ◽  
Political Consumerism ◽  
Control Laws ◽  
The Past ◽  
The Us

Cannabis (marijuana) is the most commonly consumed, universally produced, and frequently trafficked psychoactive substance prohibited under international drug control laws. Yet, several countries have recently moved toward legalization. In these places, the legal status of cannabis is complex, especially because illegal markets persist. This chapter explores the ways in which a sector’s legal status interacts with political consumerism. The analysis draws on a case study of political consumerism in the US and Canadian cannabis markets over the past two decades as both countries moved toward legalization. It finds that the goals, tactics, and leadership of political consumerism activities changed as the sector’s legal status shifted. Thus prohibition, semilegalization, and new legality may present special challenges to political consumerism, such as silencing producers, confusing consumers, deterring social movements, and discouraging discourse about ethical issues. The chapter concludes that political consumerism and legal status may have deep import for one another.

Rethinking of Turkey’s Geopolitics together with Eastern Mediterranean. Turkish Perspective

2021 ◽  
Vol 705 (2) ◽  
pp. 45-66
Author(s):  
Arıboğan Deniz Ülke ◽  
Ibrahim Arslan
Keyword(s):  
Middle East ◽  
Raw Materials ◽  
Eastern Mediterranean ◽  
International System ◽  
The United States ◽  
The Past ◽  
Humanitarian Interventions ◽  
The Us ◽  
Transportation Accessibility ◽  
The Eu

In the studies carried out within the scope of geopolitical discipline, the expression "geography is destiny" is frequently used and it is claimed that geography has unchangeable, irreversible qualities and the policies implemented are shaped through this assumption. This assumption ignores the humanitarian interventions over the geography and makes it difficult to understand the results produced by these interventions at both regional and global level. Similarly, the dynamic nature of international relations reveals new actors in the international system in times of bounce and collapse, and the borders that expand or narrow with each transformation can differentiate the geopolitical view with new sovereign countries. In the historical process, transportation accessibility, trade, search for raw materials, security and alliance relations have caused the same geography to be interpreted differently in different periods. This situation also applies to the geography of Turkey had been the homeland of empires. The developments in the Middle East over the past two decades has created a sensitivity in the relations between Turkey and the West, especially the United States. Competing interests with the EU and the US in the Middle East and the Eastern Mediterranean, has necessitated a reassessment of Turkey's geography.

Emerging Patterns in the Judicial Determination of FRAND Rates: Comparable Agreements and the Top-Down Approach for FRAND Royalties Determination

2020 ◽  
Vol 69 (9) ◽  
pp. 885-892
Author(s):  
Haris Tsilikas
Keyword(s):  
Case Law ◽  
The Past ◽  
The Us ◽  
Emerging Patterns ◽  
Common Thread ◽  
The Common ◽  
Practical Guidance ◽  
Licensing Agreements ◽  
The Eu

Abstract The massive adoption of wireless technologies over the past decades has also brought about disputes regarding the interpretation of FRAND in the context of actual commercial relations. Courts in several jurisdictions worldwide ‒ in the EU, the US, China, India and Korea, among others ‒ have been called upon to flesh out FRAND terms or to assess conformity with FRAND principles. This body of case law provides rich insights into the workings of the markets for standards, but also practical guidance for parties as well as policymakers seeking a better understanding of the situation ‒ business and legal ‒ on the ground. The present article outlines some of the emerging patterns in SEP litigation worldwide, focusing on the judicial determination of FRAND rates. The common thread across jurisdictions regarding FRAND-rate determination is reliance on evidence and data in comparable licensing agreements. It is argued that comparable licensing agreements, i.e. licensing agreements signed with similarly situated parties, provide for the most reliable evidence on how markets price standardised technologies and SEPs.

scholarly journals How Much Market Access? A Case Study of Jordan's Exports to the EU

2018 ◽  
Vol 18 (3) ◽  
pp. 431-449 ◽  
Author(s):  
STEPHANIE BRUNELIN ◽  
JAIME DE MELO ◽  
ALBERTO PORTUGAL-PEREZ
Keyword(s):  
Market Access ◽  
Refugee Crisis ◽  
Special Economic Zones ◽  
Contributing Factors ◽  
The Us ◽  
Textiles And Apparel ◽  
Economic Zones ◽  
The Eu

AbstractThe value of preferential market access schemes has fallen sharply. Drawing on a relaxation announcement of July 2016 simplifying origin requirements for access to the EU that should help improve market access, thereby contributing to alleviate the refugee crisis in Jordan, this paper argues that a simplification of origin requirements is a straightforward way to enhance preferential market access. Yet, the EU decision limits the beneficiaries who must be located in designated special economic zones, which limits preferential market access. The paper compares the performance of Jordanian exports to the EU and the US under their respective FTAs. It shows that Jordanian exports to the US have grown more rapidly than exports to the EU over the last 15 years. The study documents lower utilisation of preferences in the EU than in the US, especially in Textiles and Apparel (T&A) in spite of non-negligible preferences. Three contributing factors are identified: (i) higher adjusted preferences for apparel in the US than in the EU; (ii) greater competition from other suppliers (mostly from LDCs) in the EU market than in the US market; (iii) simpler origin requirements in the case of the Jordan–US FTA. Comparative evidence from the two FTAs and econometric estimates suggest that this should help restore market access for Jordanian exports to the EU. These estimates provide additional evidence that origin requirements suppress market access. Other pathways to simplify origin requirements are offered in the conclusion.

The Globalization of Carbon Trading: Transnational Business Coalitions in Climate Politics

2011 ◽  
Vol 11 (2) ◽  
pp. 26-50 ◽  
Author(s):  
Jonas Meckling
Keyword(s):  
Global Climate ◽  
Low Cost ◽  
Policy Instrument ◽  
Carbon Trading ◽  
Environmental Groups ◽  
Climate Politics ◽  
The Past ◽  
The Us ◽  
The Uk ◽  
The Eu

Over the past decade, carbon trading has emerged as the policy instrument of choice in the industrialized world to address global climate change. In this article I argue that a transnational business coalition, representing mostly energy firms and energy-intensive manufacturers, actively promoted the global rise of carbon trading. In this process, business was able to draw on the support of government allies and business-oriented environmental groups, particularly in the UK and the US. Alongside its allies, the coalition had pivotal influence in the internationalization of carbon trading through the Kyoto Protocol, in the U-turn of the EU from skeptic to frontrunner on carbon trading and in the re-import of carbon trading to the US. While business was not able to prevent mandatory emission controls, it was able to critically affect the regulatory style of climate policy in favor of low-cost, market-based options.

The World Economy

2003 ◽  
Vol 183 ◽  
pp. 8-33
Keyword(s):  
South America ◽  
World Economy ◽  
Consumer Demand ◽  
Modest Improvement ◽  
Cyclical Variation ◽  
The Past ◽  
The Us ◽  
The World ◽  
The Eu

Risks of a US driven slowdown in world activity have receded in the past few months, as US consumer demand remains robust. However, a worsened outlook for Germany and Japan suggests that the recovery will be more gradual than previously anticipated, in part as a consequence of the strengthening of the euro and the yen against the dollar in recent months. We estimate that world growth recorded a modest improvement in 2002, rising to 2.7 per cent from 2.2 per cent in 2001. However, regional cyclical variation increased last year. While 2001 saw a sharp slowdown in growth across all the major regions of the world, with the world's three largest economies recording outright recessions, growth accelerated last year in the US, China and Dynamic Asia, but slowed further in the EU, Japan and South America.

scholarly journals Current State of Regulatory Oversight of Biosimilars in India and Its Implications on the Quality of Drugs: A Comparative Assessment with EU and FDA Regulations

2021 ◽  
pp. 1-7
Author(s):  
Vikram Gota ◽  
◽  
Diana Varghese ◽  
Shayma Karbelkar ◽  
◽  
...  
Keyword(s):  
Quality Characteristics ◽  
Patient Access ◽  
Approval Process ◽  
Regulatory Oversight ◽  
Medical Needs ◽  
Current State ◽  
The Us ◽  
Improve Patient ◽  
Unmet Medical Needs

Biosimilars are biologic products that are highly similar to a licensed reference biologic, with no clinically meaningful differences in quality characteristics, biological activity, safety, or efficacy. Biosimilars can help to fulfill unmet medical needs due to their cost effectiveness while at the same time being as efficacious as the innovator drug. They can also improve patient access to otherwise costly innovator biologics. India has the largest number of approved biosimilars as compared to the US and Europe. However, the numbers of clinical studies that are conducted to prove the biosimilarity are lesser than the number of biosimilars approved, which is evident by the number of CTRI registrations done. Some studies have shown the quality of biosimilars approved and marketed in India to be inferior to the innovator drug. This raises concerns regarding the quality of the biosimilars. In this review, the similarities and differences in the guidelines, the approval process, and quality enforcement measures prevailing in the three regulatory regions of USA, Europe and India are discussed. Changes in the approval process and post approval monitoring of drugs and manufacturing facilities are recommended in order to ensure sustained quality standards of drugs entering the market.

Sign in / Sign up

Export Citation Format

Share Document