Generics and Biosimilars

2018 ◽  
Author(s):  
Stuart O. Schweitzer ◽  
Z. John Lu
Keyword(s):  
United States ◽  
Price Competition ◽  
Strategic Behavior ◽  
The United States ◽  
Approval Process ◽  
Biological Drugs ◽  
Patent Term ◽  
Important Player ◽  
Generic Products ◽  
Regulatory Significance

The generic pharmaceutical industry is arguably the most important player in the quest for affordable healthcare, especially in the United States. Since the inception of the industry following the enactment of the Drug Price Competition and Patent Term Restoration Act in 1984, generics have grown by leaps and bounds, and by 2015 they accounted for almost 90 percent of prescriptions filled in the United States. This chapter describes the history, industrial organization, regulatory approval process, price competition, and strategic behavior in this vitally important sector. It also provides an in-depth look at the issue of drug shortages, which affect older, generic products the most. The last part of the chapter examines the rising financial and regulatory significance of biosimilar drugs, which are analogous to generics for biological drugs, in the United States and Europe.

A Comparative Study of Pharmaceutical Incentives to Patents in India, USA and Europe

2020 ◽  
Vol 07 ◽  
Author(s):  
Renu Kadian ◽  
Arun Nanda
Keyword(s):  
United States ◽  
European Union ◽  
Intellectual Property Rights ◽  
United States Of America ◽  
Financial Support ◽  
Development Process ◽  
The United States ◽  
Drug Development Process ◽  
Data Exclusivity ◽  
Patent Term

Background:: Protection of Intellectual Property Rights is a clear incentive to innovations; yet, several countries have provided further incentives to patents in pharmaceuticals because the full patent term of 20 years is largely exhausted, before marketing authorization. Objective:: The purpose of this article is to describe the various incentives to patents in the form of financial support, data exclusivity and most importantly extended market exclusivities and comparison of various incentives to patents in the United States of America, European Union and India. Methodology:: The detail of incentives is collected from various articles, latest topics, books, and newspapers. Result:: These incentives create a positive surrounding to encourage the drug development process, strengthen economic growth and improve a balance between new pharmaceuticals in the market and access of that medicine to general public at a reasonable price. Conclusion:: European Union and the United States of America are leading in the field of incentives to patenting in phar-maceuticals as compared to India. Indian Patent Act, 1970, needs to be re-looked in terms of data exclusivity and patent term extensions.

A Follow-On Biological Drug is not a Biogeneric: Lessons from Omnitrope and Valtropin

2009 ◽  
Vol 6 (3) ◽  
pp. 237-245 ◽  
Author(s):  
Robert I. Roth ◽  
Nicholas M. Fleischer
Keyword(s):  
United States ◽  
Therapeutic Proteins ◽  
Cost Savings ◽  
The United States ◽  
Substantial Cost ◽  
Biological Drugs ◽  
Biological Drug ◽  
Therapeutic Properties ◽  
Drug Developer ◽  
The Eu

Recent years have seen the approvals, more so in the EU than the United States, of follow-on biological drugs. These products have been new formulations of recombinant therapeutic proteins, developed to compete with the marketed originator products. Intended to closely mimic the originator products in terms of chemistry and therapeutic properties, these so-called ‘biosimilar’ products were initially conceived to be developed according to abbreviated development programmes, presumably at a substantial cost savings to both the drug developer and the consumer. With several such products now recently approved, however, it has become clear that their development programmes have been quite extensive and not particularly abbreviated. Accordingly, cost savings to consumers appear to be relatively modest.

scholarly journals Generic Drugs Not as Safe as FDA Wants You to Believe

2019 ◽  
Vol 54 (3) ◽  
pp. 283-286 ◽  
Author(s):  
C. Michael White
Keyword(s):  
United States ◽  
Prescription Drugs ◽  
Generic Drugs ◽  
The United States ◽  
Drug Supply ◽  
Active Pharmaceutical Ingredients ◽  
Pharmaceutical Ingredients ◽  
Time Horizons ◽  
Long Time ◽  
Generic Products

Food and Drug Administration (FDA) rules for the production of prescription drugs are very rigorous and, if followed, guarantees a safe drug supply. For many years, foreign manufacturers have produced substandard generic products and active pharmaceutical ingredients and shipped them into the United States. If the FDA had inspected them with the same rigor as they do domestic manufacturers, they would have found many of these egregious deviations from ethical manufacturing much earlier. Although the FDA is finally stepping up the number of inspections, their current processes still rely on preannounced inspections with long time horizons, so quality issues can be temporarily corrected and documents altered or destroyed.

Drugs and Alcohol: US Prohibition and the Origins of the Drug Trade in Mexico, 1910–1930

2002 ◽  
Vol 34 (1) ◽  
pp. 21-42 ◽  
Author(s):  
GABRIELA RECIO
Keyword(s):  
United States ◽  
Twentieth Century ◽  
Alcohol Consumption ◽  
The United States ◽  
Drug Trade ◽  
Active Participant ◽  
Drugs And Alcohol ◽  
Illicit Markets ◽  
Important Player ◽  
Drug And Alcohol

Even though Mexico has been an important player in the international drug trade, this country's history in such illegal ventures has been insufficiently studied. In an effort to begin to understand how and when the country began to be an active participant in such illicit markets, this article first analyses regulations introduced in the United States regarding drug and alcohol consumption, marketing and production and assesses their impact on the Mexican side. Secondly, it argues that Mexico's participation in the narcotics trade, the routes that have developed and the Mexican states involved in this traffic have roots that can be traced to the beginning of the twentieth century at least.

scholarly journals Are controlled companies underperforming?

2020 ◽  
Vol 19 (4) ◽  
Author(s):  
Linh Le ◽  
Dongfang Nie
Keyword(s):  
United States ◽  
Firm Performance ◽  
Ownership Structure ◽  
Capital Market ◽  
Keyword Search ◽  
Research Question ◽  
The United States ◽  
Fiscal Year ◽  
The Us ◽  
Important Player

Research Question: Are controlled companies underperforming in the United States? Motivation: Anecdotal evidence shows that the average market capitalization of controlled firms increased from $8.3 billion in 2005 to $20.6 billion in 2015. Given the rapid increase in capitalization, the group of controlled companies has become an important player in the US capital market. However, little is known about controlled companies. Idea: We examine whether controlled companies are underperforming relative to non-controlled companies in the United States. Data: The data sample consists of 351 listed companies in the United States for the fiscal year 2014. Tools: 176 controlled companies were manually collected by performing the keyword search “controlled company” from the U.S. Securities and Exchange Commissions (SEC) website via “www.seekedgar.com/”. Specifically, we search “controlled company” from proxy statement DEF 14A. Each controlled company is verified after reading through the proxy statement. Findings: Using 176 controlled companies and 176 random sampled non-controlled companies, we find that controlled companies are underperforming compared to non-controlled companies. Contribution: To the best of our knowledge, we are the first to collect the group of controlled companies in the US and we are among the first to study how firm performs under the type II agency problem (Pantzalis et al. 1998). We contribute to the stream of literature on how ownership structure (e.g., family-controlled firms) affects firm performance (Anderson & Reeb, 2003). Consistent with the findings from family-controlled firms, we show that ownership structure affects firm performance. Out study sheds light on the important role of controlled companies in the US capital market.

scholarly journals Ending Abuse of Patent Continuations

2016 ◽  
Author(s):  
Mark Lemley
Keyword(s):  
United States ◽  
Empirical Data ◽  
The United States ◽  
Original Dataset ◽  
Patent Term ◽  
The World ◽  
Patent Applications

One of the oddest things to an outsider about the United States patentsystem is that due to continuation practice it is impossible for the U.S.Patent and Trademark Office (PTO) ever to finally reject a patentapplication. Continuation applications have led to abuse of the patentprosecution process. They serve very little useful purpose, and whatbenefits they confer may be outweighed by their potential for mischief. Inan effort to study the pervasiveness of continuation practice, we compiledan original dataset comprising 2,224,379 patents, every patent issued from1976 through 2000. We found that while continuations are filed in 23% ofall patent applications, patents based on continuation applicationsrepresent 52% of all litigated patents. Although continuations are used ina minority of all patents, it is the most important minority because it isthe minority most likely to end up in litigation. We examine the effortsundertaken to control the problems associated with continuation patents(changing the patent term, publishing applications, prosecution laches) andfind them insufficient. The world would probably be a better place if theywere abolished. Recognizing, however, that the abuse of continuationpractice is not as pervasive as some might think, we propose a number ofmeans by which Congress and the courts could strengthen existing rulesdesigned to limit their abuse while preserving the practice. At a minimum,the empirical data we present can provide litigants and judges with abaseline for assessing the reasonableness of delay caused by the filing ofmultiple continuations by the patentee in determining the applicability ofequitable remedies such as prosecution laches.

scholarly journals The Biologics Price Competition and Innovation Act 10--A Stocktaking

2021 ◽  
Vol 7 (1) ◽  
pp. 81-109
Author(s):  
Yaniv Heled
Keyword(s):  
United States ◽  
Price Competition ◽  
Original Data ◽  
The United States ◽  
Measurement Tool ◽  
President Obama ◽  
Current Form ◽  
Track Record ◽  
Patient Protection ◽  
Before And After

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (“Obamacare”). The purpose of BPCIA was to create for biologics a regime similar to that of the Drug Price Competition and Patent Term Restoration Act (Hatch–Waxman Act) and, in so doing, to open biologics markets to competition and, subsequently, lower the price of these expensive and increasingly important pharmaceuticals. Using original data, this Essay takes stock of the decade that has passed since the enactment of BPCIA. This Essay surveys the state of competition in United States biologics markets, entry of follow-on biologics into these markets, and the effects such entry has had on biologics prices. This Essay’s main findings are that, as of March 23, 2020—exactly ten years since the signing of BPCIA into law—the FDA has approved a total of 26 follow-on biologics deemed biosimilar to 9 original products (ratio: 2.63 follow-on/original products), with only 16 of these deemed biosimilar to 7 original products (ratio: 1.78 follow- on/original products) actually available on the market. None of these follow-on products have been approved as interchangeable with their reference products, which means that substitution of the 7 original products with one of their 16 approved biosimilars cannot be done automatically. The price of these products was 10%–37% lower than the price of the original biologic, with the average price savings being 24% or 27%. All 35 approved follow-on and reference products are owned by a total of 11 pharmaceutical companies. The number of years of market exclusivity of the 9 original biologics before the approval of the first biosimilar ranged between 13.5–28.92 with an average of 18.27 years or 15.33–29.42 with an average of 19.87 years before the launch of the first competing biosimilar. This Essay further puts forward a new method of measuring comparative levels of competition in drug markets by comparing the ratio of total approved follow-on products per total approved original products at certain critical benchmarks. Using this measurement tool, this Essay compares BPCIA’s track record with the levels of competition in small-molecule drugs before and after the Hatch– Waxman Act, showing that that BPCIA significantly underperforms in comparison and fails to instigate levels of competition that would lead to significant price drops and increase access to biologics in the United States. A short survey of the most likely reasons for BPCIA’s underperformance follows. This Essay concludes by presenting the following question: if BPCIA’s current track record is (still) not enough to convince that it is failing to meet its goals, what more would it take to reach such a conclusion, and how much longer should policymakers wait before it is possible to surmise that BPCIA in its current form has failed to significantly increase access to biologics in the United States?

Overview of Mechanical Harvesting in Florida Citrus

2001 ◽  
Author(s):  
G. K. Brown
Keyword(s):  
United States ◽  
Free Trade ◽  
Price Competition ◽  
The United States ◽  
Total Production ◽  
Worldwide Production ◽  
Economic Forces ◽  
Florida Citrus

Florida produces more citrus than all other states in the United States. In 1999, the total bearing area was estimated at 315,900 ha, and 245,000 ha were oranges (Anon, 2000). Recently, oranges averaged 77% of the total production and about 95% were processed. Orange production is projected to increase unless US weather, disease, labor, or economic forces act to depress production (Anon, 1993). Worldwide production and price competition in processed oranges are projected to decrease US grower returns, as free-trade conditions progress. Paper published with permission.

Drug Approval Process in the United States

2018 ◽  
Author(s):  
Stuart O. Schweitzer ◽  
Z. John Lu
Keyword(s):  
United States ◽  
Basic Research ◽  
Drug Approval ◽  
The United States ◽  
Approval Process ◽  
Animal Testing ◽  
Life Saving ◽  
Depth Analysis ◽  
Drug Approval Process ◽  
Major Drug

The drug approval process in any country involves a balancing of conflicting social objectives: safety and access. Faster approval leads to quicker access to potentially life-saving medicine, yet could also lead to false positives or, worse, unsafe products on the market. The United States has a widely respected but stringent and rigorous review process overseen by the Food and Drug Administration. This chapter performs an in-depth analysis of the pharmaceutical regulatory approval process in the United States. Standards, guidelines, and critical milestones for basic research, animal testing, and clinical trials in the drug R&D process are explained. It highlights major drug legislation since the beginning of the twentieth century and how this legislation has helped the FDA become the gold standard in pharmaceutical regulation worldwide. The registration pathways for generics and biosimilars are also discussed.

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