Prospects and Challenges for the Commercialization of Biosimilars: Perspectives from the EU, Japan, and the US

2016 ◽  
Vol 22 (3) ◽  
Author(s):  
Joanna Brougher
Keyword(s):  
Cost Effective ◽  
Global Market ◽  
Biologic Therapies ◽  
Biologic Drugs ◽  
Biological Products ◽  
The Us ◽  
Key Aspects ◽  
The U.S ◽  
The Eu

With many blockbuster biologic drugs coming off patent in the next couple of years, biosimilars are making significant breakthroughs in cost-effective biologic therapies. The global market for biosimilars is expected to increase nearly 30 fold from $1.3 billion in 2013 to $35 billion by 2020. To promote biosimilar development and commercialization in the U.S., the Biosimilars Act was signed into law in 2010 to establish an abbreviated pathway by which the FDA could approve biosimilar versions of previously licensed biological products. Since its enactment, two biosimilars have been approved in the U.S. This Article will discuss key aspects of the U.S., the EU and Japanese approval pathways and will explore their likely impact on the commercialization of biosimilar medicines.  

scholarly journals Biosimilar approval and checkpoints

2021 ◽  
Vol 7 (2) ◽  
pp. 141-145
Author(s):  
Sunil Chaudhry ◽  
Avisek Dutta
Keyword(s):  
Microbial Contamination ◽  
Reference Product ◽  
The United States ◽  
Global Market ◽  
Biologic Drugs ◽  
Biological Products ◽  
Regulated Markets ◽  
Autoimmune Conditions ◽  
Us Fda ◽  
Domestic Companies

Biologic drugs and subsequently developed biosimilars treat chronic inflammatory autoimmune conditions such as rheumatoid or psoriatic arthritis, ankylosingspondylitis, crohn's disease, ulcerative colitis, and psoriasis. Biologics can target the cancer in a specific way and may work synergistically with chemotherapy to improve outcome. It is expected that in the next five years, 50% of biological products will originate from biotechnology. Biological products, including those manufactured by biotechnology, tend to be heat sensitive and susceptible to microbial contamination. There are no expected clinically meaningful differences in efficacy and safety between a biosimilar and the biologic drugs which are authorized for sale. The global market for Biosimilars is dominated by oncology (nearly 39% share) whereas the total biosimilar market size is expected to reach nearly 70 billion by 2025. Biosimilars are generally marketed at prices 25 to 40 percent below original branded productsie Biologics. The number of biosimilars approved by US FDA are nearly 30. There are about 25 top global manufacturers of biosimilars. Many Domestic companies in India are making strong presence even in regulated markets.  (BPCIA) guidelines in the United States (US), mention that a biosimilar can be designated as “interchangeable”, whereby it may be substituted for the reference product (original biological drug).

scholarly journals US – EU: new priorities in the transatlantic relations

2021 ◽  
pp. 0
Author(s):  
Oleg Prikhodko
Keyword(s):  
European Union ◽  
World Order ◽  
The United States ◽  
Transatlantic Relations ◽  
The European Union ◽  
International Affairs ◽  
The Us ◽  
Important Player ◽  
The U.S ◽  
The Eu

The European Union is an important player in the U.S. policies aimed at maintaining liberal world order. The US-EU interaction has been shaped by a number of key variables, including international environment, specific goals of the U.S. administrations, institutional maturing of the EU, and a complex interplay of American and European diverging and overlapping interests. President D. Trump’s tenure was the most strained period in the US-EU relations, with an erosion of mutual trust and a ghost of trade war looming large. The Biden administration has reversed the U.S. policy towards the European Union. The US-EU summit held last June signified a return of normality in the relations of the transatlantic partners. Washington and Brussels outlined a broad agenda that embraces security, trade and economic issues, coordination in international affairs (concerning, in particular, Russia, China, and Iran), cooperation in decarbonizing of the world economy and promotion of a climate-friendly environment. A broad web of links between the United States and Europe facilitates their joining efforts in addressing global and regional challenges. Although, the US and the EU reached a series of compromises to mitigate their most acrimonious disagreements (Boeing–Airbus subsidies dispute is a vivid example in this regard), there are still unsettled major issues like a comprehensive free trade treaty unsuccessfully negotiated since the Obama presidency. The “Chinese factor” may turn out to be the most divisive one in the transatlantic relations, since the U.S. tough policy towards Beijing makes the EU countries to take hard decisions they prefer to avoid. While it is premature to predict precise implications of the Biden administration’s policy, one can reasonably expect the EU to become a more helpful partner to Washington in diplomatic and economic affairs.

Brexit will accentuate global market distortions

2016 ◽  
Keyword(s):  
Interest Rates ◽  
Global Market ◽  
Bond Yields ◽  
Equity Prices ◽  
Content Type ◽  
Us Economy ◽  
The Us ◽  
The Uk ◽  
Economic Outlook ◽  
The Eu

Subject Outlook for post-Brexit markets. Significance The UK vote to leave the EU is exacerbating distortions in financial markets. Government bond and equity prices are rising, sending contradictory signals about the global economic outlook. Yields on US and German bonds partly retraced their steps last week as initial fears about the consequences of the Brexit vote diminished. However, the yield on ten-year Treasuries remains 20 basis points (bp) lower than on referendum day, June 23, and the S&P 500 index stands close to a record high. The expanding universe of negative bond yields is fuelling investor appetite for risk assets, including equities. Impacts Markets may be underestimating the likelihood of higher US interest rates given recent signals of improvement in the US economy. Demand for safe-haven assets could stay strong, with the price of gold rising 5.6% since the referendum. Heightened uncertainty may mean that the oil price rally is over; it could even reverse given the persistent supply glut.

Agencificationin the United States and Germany and What the EU Might Learn From It

2016 ◽  
Vol 17 (2) ◽  
pp. 119-152
Author(s):  
Merijn Chamon
Keyword(s):  
European Union ◽  
Separation Of Powers ◽  
The United States ◽  
The European Union ◽  
Legal Basis ◽  
Federal Level ◽  
The Past ◽  
The Us ◽  
The U.S ◽  
The Eu

In the European Union the legislature has, in the past years, established an increasing number of agencies, granting them increasingly important powers. This phenomenon of agencification is legally problematic because it does not have a legal basis in the EU Treaties. In order to better understand the challenges posed by EU agencification, this Article looks at similar agencification processes in two other federal-type polities, the U.S. and Germany. Germany is especially relevant to understanding the vertical (federal) dimension to EU agencification, while the U.S. experience can inform us about the horizontal (separation of powers) dimension. This is done by looking at three distinct issues: The question of the initial establishment of a new body at the EU (federal) level, the extent to which powers can be entrusted to such a body, and the degree to which the decisions adopted by such bodies are judicially scrutinized. The Article concludes that EU agencification poses a greater risk than agencification in Germany or the US because control is partially less well-established (compared to Germany) and because the EU polity is much less mature (compared to the U.S.).

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.

Russian Policy of Agriculture Support and the Necessity of Its Modification after WTO Accession

2012 ◽  
pp. 132-149 ◽  
Author(s):  
V. Uzun
Keyword(s):  
Comparative Analysis ◽  
World Trade Organization ◽  
Agricultural Production ◽  
World Trade ◽  
The Us ◽  
The World ◽  
Wto Accession ◽  
The Eu ◽  
Agriculture Support

The article deals with the features of the Russian policy of agriculture support in comparison with the EU and the US policies. Comparative analysis is held considering the scales and levels of collective agriculture support, sources of supporting means, levels and mechanisms of support of agricultural production manufacturers, its consumers, agrarian infrastructure establishments, manufacturers and consumers of each of the principal types of agriculture production. The author makes an attempt to estimate the consequences of Russia’s accession to the World Trade Organization based on a hypothesis that this will result in unification of the manufacturers and consumers’ protection levels in Russia with the countries that have long been WTO members.

Problems of the US Economic Policy

2013 ◽  
pp. 129-143
Author(s):  
V. Klinov
Keyword(s):  
Economic Policy ◽  
Real Estate ◽  
Full Employment ◽  
Tax Rates ◽  
Equitable Distribution ◽  
Investment Rate ◽  
The Us ◽  
Budget Systems ◽  
Enterprise Activity ◽  
The U.S

How to provide for full employment and equitable distribution of incomes and wealth are the keenest issues of the U.S. society. The Democratic and the Republican Parties have elaborated opposing views on economic policy, though both parties are certain that the problems may be resolved through the reform of the federal tax and budget systems. Globalization demands to increase incentives for labor and enterprise activity and for savings to secure proper investment rate. Tax rates for labor and enterprise incomes are to be low, but tax rates for consumption, real estate and land should be progressive.

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.

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