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.

scholarly journals Albanian National Action Plan for Roma Inclusion 2016–2020: A Study on the Program Achievements at the Halfway Mark

SAGE Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 215824402110361
Author(s):  
Gentian Qejvanaj
Keyword(s):  
Action Plan ◽  
Communist Regime ◽  
Background Information ◽  
Structured Interviews ◽  
National Action Plan ◽  
Current State ◽  
The Us ◽  
Implementation Period ◽  
Education And Employment

Roma segregation in Albania has been causing growing concern since the fall of the communist regime. In this study, we analyze the effectiveness of the Albanian national action plan for Roma inclusion 2016–2020, in 2018, halfway in its implementation period. We gathered data on education and employment from the pre-implementation period (2015) and compared it with the latest available data in 2018. Interviews with local experts and surveys by the Balkan Barometer will provide background information to assess the current state of Roma integration in Albania. Moreover, descriptive statistics from national and international institutions and structured interviews will draw an independent narrative of Roma affairs. In our conclusion, we suggest moving beyond the “us and them” approach with programs run on inertia; our findings highlight that although encouraging achievements have been reached under the 2016–2020 action plan, real inclusion is still far, as statistical achievements do not say much about the quality of the education or job training provided under the 2016–2020 action plan.

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 Factors Affecting Health-Related Quality of Life in Multimorbidity

Healthcare ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 334
Author(s):  
Eunmi Lee ◽  
Sunkyung Cha ◽  
Geun Myun Kim
Keyword(s):  
Quality Of Life ◽  
Health Behaviors ◽  
Private Insurance ◽  
Subjective Health ◽  
Health Related Quality ◽  
Medical Needs ◽  
Related Quality ◽  
Health Related ◽  
Unmet Medical Needs

We investigated the effect of predisposing, enabling, need factors, and health behaviors on health-related quality of life (HRQoL) of patients with multimorbidity according to Andersen’s model. This study is a secondary analysis of population-based cross-sectional surveys. Data from 328 patients with multimorbidity (≥3 co-occurring chronic diseases) from the 6th/7th Korea National Health and Nutrition Examination Surveys were analyzed using logistic regression. Patients ≥65 years, without private insurance, with poor subjective health, unmet medical needs, and/or limited activity were more likely to experience mobility problems. Self-care problems were more likely among those without private insurance and/or with limited activity. Patients lacking living security, with poor subjective health, limited activity, and/or who smoked were more likely to experience problems performing usual activities. Pain/discomfort was more likely among females, Medicaid beneficiaries, and patients with limited activity and/or with poor subjective health. Patients with poor subjective health, limited activity, and/or unmet medical needs were more likely to experience anxiety/depression. The investigation of HRQoL in multimorbidity should consider predisposing, enabling, need factors, and health behaviors. Interventions addressing movement restrictions and personalized care based on HRQoL domains should be prioritized.

scholarly journals 3200 Balancing Cost and Quality of Care in the US and Denmark: Lessons for Nations Transitioning from Volume-Based to Value-Based Care

2019 ◽  
Vol 3 (s1) ◽  
pp. 140-140
Author(s):  
Negin Fouladi ◽  
Margit Malmmose
Keyword(s):  
Decision Making ◽  
Quality Of Care ◽  
Control Strategies ◽  
Decision Makers ◽  
Sources Of Information ◽  
Healthcare Organizations ◽  
Regulatory Oversight ◽  
Physician Practices ◽  
The Us

OBJECTIVES/SPECIFIC AIMS: Promote knowledge translation and evidence-informed decision-making by assessing barriers and facilitators to balancing cost and quality of care within the US state of Maryland and nation of Denmark. METHODS/STUDY POPULATION: Open-ended and semi-structured key-informant interviews were conducted in 2016 and 2017 among high level decision-makers in Maryland (N=21) and the Danish (N=17) healthcare systems, including hospital, local, regional, and cross-organizational administrators and elected officials. The interviews consisted of questions related to: (1) currently practiced and preferred approaches to resource allocation and development and use of quality performance measures, and (2) preferred sources, formats/styles, modes of information, and decision-making strategies based on a shift from volume to quality-driven care. RESULTS/ANTICIPATED RESULTS: Decision-makers in Maryland expressed the need for collaboration in a changing environment, yet increasingly rely on cost and quality outcomes data to drive decisions and note the struggle to identify credible and useful information. Maryland decision-makers also face challenges in regulating utilization and costs without mandated participation of physician practices within the global budget cap model, which is perceived to be a primary driver of healthcare utilization in the hospital sector. Similarly, decision-makers in Denmark conveyed the importance of quantitative data to aid decisions, however, stress collaboration and dialogue as driving factors and important sources of information. Danish decision-makers also express challenges to wide-spread adoption of a quality-driven approach due to unsustained quality assurance regulatory bodies. DISCUSSION/SIGNIFICANCE OF IMPACT: The findings suggest implementation of value-based healthcare is highly driven and influenced by availability of credible data, which may significantly impact development of policies and innovative cost control strategies, and regulatory oversight to promote adoption of quality measures in decision-making. Furthermore, collaboration within and across healthcare organizations remains a key component to health system improvement as it fosters dialogue and sharing of best practices among stakeholders.

FDA at BIO 2011 – Weighing a hefty mission: Where is the balance?

1969 ◽  
Vol 17 (4) ◽  
Author(s):  
Suzanne Levy
Keyword(s):  
Nonprofit Sector ◽  
The United States ◽  
Biotechnology Industry ◽  
Washington Dc ◽  
Current State ◽  
Industry Organization ◽  
The Us ◽  
Quality Of Food ◽  
Biotechnology Industry Organization

The mission of the Food and Drug Administration (FDA) is to promote public health by ensuring the safety and quality of food and medical products sold in the United States. At this year's annual Biotechnology Industry Organization (BIO) convention, significant discussion revolved around the appropriate interpretation and execution of that mission.The BIO meeting hosted 15 646 participants from across industry, government and the nonprofit sector, focusing on the current state of the biotechnology industry, as well as its challenges in seeking to further improve public welfare. Perhaps partly because this year's meeting was held in Washington, DC – the seat of the federal government and of BIO's headquarters – much attention was paid to the US regulatory environment. In particular, attendees debated the quandary faced every day by the FDA: how to enable access to novel therapies quickly, but only once their safety has been certified.

Wishes and worries of haemophilia patients

2017 ◽  
Vol 37 (02) ◽  
pp. 117-126
Author(s):  
Herbert Lechner ◽  
Anja Schleiermacher ◽  
Karin Berger ◽  
Dorothee Schopohl ◽  
Wolfgang Schramm
Keyword(s):  
Medical Care ◽  
Psychosocial Support ◽  
Age Groups ◽  
Future Health ◽  
Medical Needs ◽  
Current State ◽  
Care And Support ◽  
High Level ◽  
Unmet Medical Needs ◽  
Improve Health

SummaryHaemophilia care in Germany has achieved a high level and enables the majority of patients to lead a largely normal life. The Bluter Betreuung Bayern e.V. (BBB) aims to improve health care and support for haemophilia patients. A questionnaire has been developed by BBB representatives to evaluate unmet medical needs from the patient perspective. It was sent to 290 haemophilia patients and/or their parents in Bavaria in November 2015. The response rate was 51.4 %: 66 children aged < 15 years (66.7 % severe), 30 patients 15–24 years (66.7 % severe), 26 patients 25–44 years (80.8 % severe), 24 patients > 44 years (95.8 % severe). Prophylactic therapy in patients with severe haemophilia aged < 25 and ≥ 25 years is given “always” in ≥ 80 % and > 60 %, respectively. Substitution therapy is mostly uncomplicated. Satisfaction with medical care is high. Chronic pain is a problem with increasing age. Patients aged 25–44 years worry least regarding future health, safety and availability of factor products, patients > 44 years most. Overall, 80–100 % of the patients from all age groups are interested in information on the current state of science. Offers of the BBB for psychosocial support in addition to the medical care seem to be helpful and needed in all age groups.

scholarly journals An IHE-conform telecooperation platform supporting the treatment of dementia patients

2015 ◽  
Vol 1 (1) ◽  
pp. 310-313
Author(s):  
K. Saleh ◽  
D. Ammon ◽  
S. Lehnert ◽  
S. Röhr ◽  
V. Detschew ◽  
...  
Keyword(s):  
Health Care Professionals ◽  
Rural Areas ◽  
Patient Treatment ◽  
Electronic Patient Records ◽  
Medical Needs ◽  
Intersectoral Cooperation ◽  
Dementia Patients ◽  
Different Types ◽  
Unmet Medical Needs

AbstractEnsuring medical support of patients of advanced age in rural areas is a major challenge. Moreover, the number of registered doctors—medical specialists in particular—will decrease in such areas over the next years. These unmet medical needs in combination with communication deficiencies among different types of health-care professionals pose threats to the quality of patient treatment. This work presents a novel solution combining telemedicine, telecooperation, and IHE profiles to tackle these challenges. We present a telecooperation platform that supports longitudinal electronic patient records and allows for intersectoral cooperation based on shared electronic medication charts and other documents. Furthermore, the conceived platform allows for an integration into the planned German telematics infrastructure.

scholarly journals Print, Electronic, and Social Media and the Transformation of Democratic Representation

2020 ◽  
pp. 525-542
Author(s):  
Mark Peffley ◽  
Alexander Denison ◽  
Travis N. Taylor
Keyword(s):  
Social Media ◽  
Political Representation ◽  
The Internet ◽  
Media Technology ◽  
Liberal Democracies ◽  
Political Behaviour ◽  
Current State ◽  
The Us ◽  
The Media

The chapter examines the current state of print, electronic, and social media in Europe and the US, and how its evolution has influenced mass behaviour, political representation, and democratic governance. We begin by surveying the dramatic changes that have taken place in the media environment—the shift in media technology from print to broadcast to the Internet, and how these changes influence the information environment and thus, the behaviour of citizens and elites. We then assess how various facets of the electronic media—that is, broadcast news, cable, partisan news, the Internet, and social media—influence political behaviour and representation. Despite a few exceptions, transformations in print, electronic, and social media in liberal democracies have tended to degrade the quality of representation in the last two decades, particularly in the US, where market forces are stronger and government regulations designed to buffer the market are weaker.

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