The Legal and Regulatory Status of Biosimilars

2015 ◽  
Vol 41 (1) ◽  
pp. 49-84 ◽  
Author(s):  
Jordan Paradise
Keyword(s):  
Price Competition ◽  
Cost Savings ◽  
The United States ◽  
Current Debate ◽  
New Paradigm ◽  
State Laws ◽  
Patient Protection ◽  
Regulatory Status ◽  
Negative Effect ◽  
Potential Negative Effect

Alongside the constitutional controversy ultimately addressed by the Supreme Court, the colossal Patient Protection and Affordable Care Act (ACA) ushered in a new paradigm for regulation of biologics by the Food and Drug Administration (FDA). Nestled within the expansive ACA, the Biologics Price Competition and Innovation Act (BPCIA) set forth an abbreviated pathway to market for “biosimilar” and “interchangeable” biological products. While the current BPCIA implementation debate focuses chiefly on the scope of scientific and technical assessments by the FDA and the effect on the emergent biosimilar industry, two issues will prove essential for determinations of access to and costs of the resulting products: how the biosimilar and interchangeable biosimilar biologics are to be named, and whether pharmacist substitution is appropriate for products the FDA deems interchangeable. This article examines the current debate surrounding the use of nonproprietary names for biosimilar biologics, as well as state efforts to reconcile automatic substitution laws for the eventual products. In particular, the article addresses the implications for patients and the United States health care system, highlighting the potential negative effect on anticipated cost-savings, hindrances for effective tracking and reporting of adverse events, and a general lack of consistency in state laws.

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?

scholarly journals Evolution of Physician-Centric Business Models Under the Patient Protection and Affordable Care Act

2016 ◽  
Vol 15 (1) ◽  
Author(s):  
Tanya Nix ◽  
Lynn Szostek
Keyword(s):  
United States ◽  
Medical Care ◽  
Affordable Care Act ◽  
Business Models ◽  
Healthcare Delivery ◽  
The United States ◽  
New Paradigm ◽  
Medical Specialties ◽  
Patient Protection ◽  
The Cost

For decades, the cost of medical care in the United States has increased exponentially. United States citizens spend twice as much as their European counterparts on medical care. Congress enacted the Patient Protection and Affordable Care Act (PPACA) to ensure affordable healthcare to the citizens of the United States. PPACA legislation is creating a new paradigm in healthcare delivery and provider business models. The purpose of this case study was to explore physicians’ perspectives regarding physician-centric business models evolving under the requirements of the PPACA legislation. Data were gathered through semistructured interviews and questionnaires with a purposive sample of 75 participants across 20 medical specialties within the United States. Three universal themes emerged including (a) use of midlevel practitioners, (b) changes to provider practices, and (c) enhanced business education. Healthcare leaders may use the findings to advance the evolution of physician business models that meet the needs of healthcare stakeholders.

Migration and the Internet

2017 ◽  
Vol 14 (3) ◽  
pp. 331-342 ◽  
Author(s):  
Thomas John Cooke ◽  
Ian Shuttleworth
Keyword(s):  
United States ◽  
Information And Communication Technologies ◽  
Unobserved Heterogeneity ◽  
Panel Study ◽  
The United States ◽  
Negative Effect ◽  
Information And Communication ◽  
Using Data ◽  
And Migration ◽  
Dynamics Models

It is widely presumed that information and communication technologies, or ICTs, enable migration in several ways; primarily by reducing the costs of migration. However, a reconsideration of the relationship between ICTs and migration suggests that ICTs may just as well hinder migration; primarily by reducing the costs of not moving.  Using data from the US Panel Study of Income Dynamics, models that control for sources of observed and unobserved heterogeneity indicate a strong negative effect of ICT use on inter-state migration within the United States. These results help to explain the long-term decline in internal migration within the United States.

The Hard Sell

2017 ◽  
Author(s):  
Peter Scott
Keyword(s):  
Price Competition ◽  
New Economy ◽  
The United States ◽  
Vacuum Cleaner ◽  
Firm Level ◽  
Direct Sales ◽  
Cost Distribution ◽  
Household Cleaning ◽  
Time Savings ◽  
Cleaning Methods

The vacuum cleaner was an archetypal new economy product of the early twentieth century. It offered both major time savings and qualitative advantages over previous household cleaning methods—the brush, broom, and manual carpet sweeper—and was sold in a novel way (by household demonstration). The direct sales techniques pioneered by vacuum manufacturers in the United States were to have a profound impact on the way vacuums were sold in Britain, and globally. Yet by 1939 their household diffusion was relatively slow compared to refrigerators or washing machines. This chapter explores why the industry evolved a structure based on high prices, high cost distribution methods (door-to-door sales), and a strong emphasis on non-price competition, based on differentiation through features. It also shows how door-to-door selling eventually came to constitute both a key firm-level competitive advantage and a substantial industry-level constraint on product diffusion.

Digital Pollution and Its Impact on the Family and Social Interactions

2021 ◽  
pp. 0192513X2098555
Author(s):  
Shiv Ratan Agrawal
Keyword(s):  
Social Interaction ◽  
Social Interactions ◽  
Critical Dimensions ◽  
Digital Devices ◽  
The Family ◽  
Negative Effect ◽  
Potential Negative Effect ◽  
Human Attitude ◽  
Impact On Family ◽  
And Behavior

The present study was an attempt to identify the most prevailing means of digital devices and its impact as digital pollution on family and social interactions. Despite the obvious benefits of digital devices, in recent years researchers have taken more concern about its potential negative effect on human attitude and behavior, which in turn affects our society. A total of 613 usable responses were collected from Bangalore, India of excessive users of digital devices, such as a smartphone, computer/laptop, and television. All statistical analyses were performed using SPSS 23.0, AMOS 23.0, and SmartPLS 3.0. The results indicated that as the use of smartphone and computer/laptop increases, levels of digital pollution also increase, which in turn significantly triggers unfavorable impact on family and social interactions. The study indicated that digital pollution appears as an important predictor, which significantly affects social interaction unfavorably. The present study explored the various critical dimensions within this domain and delineated gaps in our knowledge of digital pollution. It was found that smartphones are more responsible for digital pollution among all the identified digital devices, followed by computer/laptop.

scholarly journals Excellence in medical training: developing talent—not sorting it

2021 ◽  
Author(s):  
Gurpreet Dhaliwal ◽  
Karen E. Hauer
Keyword(s):  
Medical Training ◽  
The United States ◽  
New Paradigm ◽  
New Model ◽  
Achievement Growth ◽  
Medical Licensing ◽  
Multiple Domains ◽  
Learning Schools ◽  
Teacher Excellence ◽  
Honor Society

AbstractMany medical schools have reconsidered or eliminated clerkship grades and honor society memberships. National testing organizations announced plans to eliminate numerical scoring for the United States Medical Licensing Examination Step 1 in favor of pass/fail results. These changes have led some faculty to wonder: “How will we recognize and reward excellence?” Excellence in undergraduate medical education has long been defined by high grades, top test scores, honor society memberships, and publication records. However, this model of learner excellence is misaligned with how students learn or what society values. This accolade-driven view of excellence is perpetuated by assessments that are based on gestalt impressions influenced by similarity between evaluators and students, and assessments that are often restricted to a limited number of traditional skill domains. To achieve a new model of learner excellence that values the trainee’s achievement, growth, and responsiveness to feedback across multiple domains, we must envision a new model of teacher excellence. Such teachers would have a growth mindset toward assessing competencies and learning new competencies. Actualizing true learner excellence will require teachers to change from evaluators who conduct assessments of learning to coaches who do assessment for learning. Schools will also need to establish policies and structures that foster a culture that supports this change. In this new paradigm, a teacher’s core duty is to develop talent rather than sort it.

scholarly journals Effect of Honey and Syrup Diets Enriched with 1,3-1,6 β-Glucans on Honeybee Survival Rate and Phenoloxidase Activity (Apis mellifera L. 1758)

2021 ◽  
Vol 8 (7) ◽  
pp. 130
Author(s):  
Simona Sagona ◽  
Baldassare Fronte ◽  
Francesca Coppola ◽  
Elena Tafi ◽  
Matteo Giusti ◽  
...  
Keyword(s):  
Apis Mellifera ◽  
Survival Rate ◽  
Significant Variation ◽  
Innate Immune ◽  
Control Group ◽  
Phenoloxidase Activity ◽  
Immune Modulators ◽  
Negative Effect ◽  
Potential Negative Effect ◽  
Combined Action

β-glucans can activate the animal innate immune system by acting as immune-modulators and inducing various stimulatory effects. The aim of this study was to investigate the effect of 1,3-1,6 β-glucans administered orally for 96 h on Apis mellifera workers (newly emerged and nurse bees). β-glucans were included in honey and syrup. Survival rate and phenoloxidase activity were measured. In both newly emerged and nurse bees, β-glucans supplementation did not affect survival rate (p > 0.05). Conversely, phenoloxidase activity was higher in both newly emerged bees (p = 0.048) and nurse bees (p = 0.014) fed with a honey diet enriched with β-glucans compared to those fed with only honey. In both the newly emerged and nurse bees, no statistical differences in phenoloxidase activity were recorded between the group fed with a syrup-based diet enriched with β-glucans and the control group (p > 0.05). The absence of significant variation in survival suggests that the potential negative effect of β-glucans in healthy bees could be mitigated by their metabolism. Conversely, the inclusion of β-glucans in a honey-based diet determined an increase of phenoloxidase activity, suggesting that the effect of β-glucan inclusion in the diet of healthy bees on phenoloxidase activity could be linked to the type of base-diet. Further investigations on β-glucans metabolism in bees, on molecular mechanism of phenoloxidase activation by 1,3-1,6 β-glucans, and relative thresholds are desirable. Moreover, investigation on the combined action of honey and β-glucans on phenoloxidase activity are needed.

scholarly journals Cost effectiveness analysis of implementing tuberculosis screening among applicants for non-immigrant U.S. work visas

Pneumonia ◽  
2020 ◽  
Vol 12 (1) ◽  
Author(s):  
Bisma Ali Sayed ◽  
Drew L. Posey ◽  
Brian Maskery ◽  
La’Marcus T. Wingate ◽  
Martin S. Cetron
Keyword(s):  
United States ◽  
Home Country ◽  
Screening Program ◽  
Cost Savings ◽  
The United States ◽  
Active Tuberculosis ◽  
Multiple Perspectives ◽  
Tuberculosis Screening ◽  
Hospitalization Costs ◽  
The U.S

Abstract Background While persons who receive immigrant and refugee visas are screened for active tuberculosis before admission into the United States, nonimmigrant visa applicants (NIVs) are not routinely screened and may enter the United States with infectious tuberculosis. Objectives We evaluated the costs and benefits of expanding pre-departure tuberculosis screening requirements to a subset of NIVs who arrive from a moderate (Mexico) or high (India) incidence tuberculosis country with temporary work visas. Methods We developed a decision tree model to evaluate the program costs and estimate the numbers of active tuberculosis cases that may be diagnosed in the United States in two scenarios: 1) “Screening”: screening and treatment for tuberculosis among NIVs in their home country with recommended U.S. follow-up for NIVs at elevated risk of active tuberculosis; and, 2) “No Screening” in their home country so that cases would be diagnosed passively and treatment occurs after entry into the United States. Costs were assessed from multiple perspectives, including multinational and U.S.-only perspectives. Results Under “Screening” versus “No Screening”, an estimated 179 active tuberculosis cases and 119 hospitalizations would be averted in the United States annually via predeparture treatment. From the U.S.-only perspective, this program would result in annual net cost savings of about $3.75 million. However, rom the multinational perspective, the screening program would cost $151,388 per U.S. case averted for Indian NIVs and $221,088 per U.S. case averted for Mexican NIVs. Conclusion From the U.S.-only perspective, the screening program would result in substantial cost savings in the form of reduced treatment and hospitalization costs. NIVs would incur increased pre-departure screening and treatment costs.

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