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).

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.  

A Database for Counterfeit Electronics and Automatic Defect Detection Based on Image Processing and Machine Learning

2016 ◽  
Author(s):  
Navid Asadizanjani ◽  
Sachin Gattigowda ◽  
Mark Tehranipoor ◽  
Domenic Forte ◽  
Nathan Dunn
Keyword(s):  
Machine Learning ◽  
Image Processing ◽  
Integrated Circuits ◽  
Web Application ◽  
The United States ◽  
Global Market ◽  
Online Database ◽  
Ongoing Effort ◽  
Time Period ◽  
Physical Defects

Abstract Counterfeiting is an increasing concern for businesses and governments as greater numbers of counterfeit integrated circuits (IC) infiltrate the global market. There is an ongoing effort in experimental and national labs inside the United States to detect and prevent such counterfeits in the most efficient time period. However, there is still a missing piece to automatically detect and properly keep record of detected counterfeit ICs. Here, we introduce a web application database that allows users to share previous examples of counterfeits through an online database and to obtain statistics regarding the prevalence of known defects. We also investigate automated techniques based on image processing and machine learning to detect different physical defects and to determine whether or not an IC is counterfeit.

The 1980s to the Present

2018 ◽  
Author(s):  
Gregory A. Barton
Keyword(s):  
United States ◽  
United Nations ◽  
Organic Farming ◽  
The United States ◽  
Global Market ◽  
Health Food ◽  
Organic Certification ◽  
Organic Farmers ◽  
The United Nations ◽  
Mainstream Press

While a few positive stories on organic farming appeared in the 1970s most mainstream press coverage mocked or dismissed organic farmers and consumers. Nevertheless, the growing army of consumer shoppers at health food stores in the United States made the movement impossible to ignore. The Washington Post and other newspapers shifted from negative caricatures of organic farming to a supportive position, particularly after the USDA launched an organic certification scheme in the United States under the leadership of Robert Bergland. Certification schemes in Europe and other major markets followed, leading to initiatives by the United Nations for the harmonization of organic certification through multilateral agencies. As organic standards proliferated in the 1990s the United Nations stepped in to resolve the regulatory fragmentation creating a global market for organic goods.

scholarly journals Postharvest Supply Chain with Microbial Travelers: a Farm-to-Retail Microbial Simulation and Visualization Framework

2018 ◽  
Vol 84 (17) ◽  
Author(s):  
Claire Zoellner ◽  
Mohammad Abdullah Al-Mamun ◽  
Yrjo Grohn ◽  
Peter Jackson ◽  
Randy Worobo
Keyword(s):  
Supply Chain ◽  
Foodborne Pathogens ◽  
Empirical Data ◽  
Microbial Growth ◽  
Microbial Contamination ◽  
Fresh Produce ◽  
The United States ◽  
Plate Count ◽  
Modeling Tool ◽  
Parameter Ranges

ABSTRACTFresh produce supply chains present variable and diverse conditions that are relevant to food quality and safety because they may favor microbial growth and survival following contamination. This study presents the development of a simulation and visualization framework to model microbial dynamics on fresh produce moving through postharvest supply chain processes. The postharvest supply chain with microbial travelers (PSCMT) tool provides a modular process modeling approach and graphical user interface to visualize microbial populations and evaluate practices specific to any fresh produce supply chain. The resulting modeling tool was validated with empirical data from an observed tomato supply chain from Mexico to the United States, including the packinghouse, distribution center, and supermarket locations, as an illustrative case study. Due to data limitations, a model-fitting exercise was conducted to demonstrate the calibration of model parameter ranges for microbial indicator populations, i.e., mesophilic aerobic microorganisms (quantified by aerobic plate count and here termed APC) and total coliforms (TC). Exploration and analysis of the parameter space refined appropriate parameter ranges and revealed influential parameters for supermarket indicator microorganism levels on tomatoes. Partial rank correlation coefficient analysis determined that APC levels in supermarkets were most influenced by removal due to spray water washing and microbial growth on the tomato surface at postharvest locations, while TC levels were most influenced by growth on the tomato surface at postharvest locations. Overall, this detailed mechanistic dynamic model of microbial behavior is a unique modeling tool that complements empirical data and visualizes how postharvest supply chain practices influence the fate of microbial contamination on fresh produce.IMPORTANCEPreventing the contamination of fresh produce with foodborne pathogens present in the environment during production and postharvest handling is an important food safety goal. Since studying foodborne pathogens in the environment is a complex and costly endeavor, computer simulation models can help to understand and visualize microorganism behavior resulting from supply chain activities. The postharvest supply chain with microbial travelers (PSCMT) model, presented here, provides a unique tool for postharvest supply chain simulations to evaluate microbial contamination. The tool was validated through modeling an observed tomato supply chain. Visualization of dynamic contamination levels from harvest to the supermarket and analysis of the model parameters highlighted critical points where intervention may prevent microbial levels sufficient to cause foodborne illness. The PSCMT model framework and simulation results support ongoing postharvest research and interventions to improve understanding and control of fresh produce contamination.

Real-world trends in biosimilar prescribing among oncology providers, 2019-2021.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18701-e18701
Author(s):  
Kelly A. McGlynn ◽  
Jacqueline McGarry ◽  
Kashyap B. Patel ◽  
Natasha Clinton
Keyword(s):  
Real World ◽  
Reference Product ◽  
The United States ◽  
Prescription Data ◽  
Nccn Guidelines ◽  
Prescribing Behavior ◽  
Product Pricing ◽  
Value Based Care ◽  
Oncology Providers ◽  
First 90 Days

e18701 Background: The number of approved biosimilars in the United States has increased exponentially in recent years. Within the oncology market, there are currently 14 approved biosimilars, with 11 launched since the start of 2019. The emergence of new oncology biosimilars provides a tool for success in value-based care, and has the potential to lower costs to patients and providers and expand access to care. Methods: Analysis of biosimilar prescribing behavior was performed using 2020 prescription data (Wolters Kluwer, n = 130,836), sales data (IQVIA), and dosage data for patients taking bevacizumab, trastuzumab, rituximab, or an FDA-approved biosimilar for these products (FDA Purple Book), between 2019-2021 (ION Solutions, n = 69,884). Drugs not directly interchangeable with the bevacizumab, trastuzumab or rituximab reference products according to NCCN guidelines were excluded. Results: Biosimilar products are currently available for bevacizumab (2 biosimilars), rituximab (3 biosimilars), and trastuzumab (5 biosimilars). We found that in 2020, 8.2% of new prescriptions for any of these three reference products were for a biosimilar. An analysis of real-world drug administration data revealed that in the 3 months following the 2019 launch of trastuzumab’s first biosimilar (trastuzumab-anns), 7.3% of initiating line 1 patients were prescribed the biosimilar over the reference product. During the same period in 2020, when a total of 5 trastuzumab biosimilars were available, 80.5% of initiating line 1 trastuzumab patients began treatment on a biosimilar, suggesting rapid uptake by providers. However, this differed by product, with the initial uptake for the first rituximab biosimilar (rituximab-pvvr), at only 2.3%. Uptake also occurred within treatment lines, with 11.1% of all patients (bevacizumab: 11.3%, trastuzumab: 14.1%, rituximab: 7.9%) switching from a reference product to a biosimilar during treatment. Uptake was particularly rapid for trastuzumab biosimilars: among patients on trastuzumab at the time of its first biosimilar launch, 18.2% switched to trastuzumab-anns in the first 90 days post-launch. Biosimilars launched at significantly lower prices than their reference products, with cost per prescription at -42.0%, -29.9% and -89.5% relative to the reference product for trastuzumab, rituximab and bevacizumab, respectively. However, biosimilar launches had little impact on reference product pricing, with 2019-2020 year-over-year (YOY) differences in price per prescription close to the YOY averages in previous years (2015-2019) for all three reference products. Conclusions: We conclude that uptake of biosimilars among oncology providers between 2019-2020 was rapid, although the extent of biosimilar prescribing varied among products. Biosimilars offered greatly reduced costs to providers, although reference product prices remained stable despite increased biosimilar competition.

scholarly journals Forest Product Trade Impacts of an Invasive Species: Modeling Structure and Intervention Trade-Offs

2006 ◽  
Vol 35 (1) ◽  
pp. 128-143 ◽  
Author(s):  
Jeffrey P. Prestemon ◽  
Shushuai Zhu ◽  
James A. Turner ◽  
Joseph Buongiorno ◽  
Ruhong Li
Keyword(s):  
Forest Products ◽  
The United States ◽  
Global Market ◽  
Forest Sector ◽  
Spatial Equilibrium ◽  
Trade Offs ◽  
Spatial Equilibrium Model ◽  
The World ◽  
Nun Moth ◽  
Market Consequences

Asian gypsy and nun moth introductions into the United States, possibly arriving on imported Siberian coniferous logs, threaten domestic forests and product markets and could have global market consequences. We simulate, using the Global Forest Products Model (a spatial equilibrium model of the world forest sector), the consequences under current policies of a widespread, successful pest invasion, and of plausible trading partner responses to the successful invasion. We find that trade liberalization would have a negligible effect on U.S. imports of Siberian logs and, consequently, on the risk of a pest invasion. But, if it happened, possibly through trade in other commodities, a successful and widespread pest invasion would have large effects on producers and consumers over the period 2002 to 2030.

scholarly journals An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period

2021 ◽  
pp. 01-06
Author(s):  
Unnati Saxena ◽  
Debdipta Bose ◽  
Shruti Saha ◽  
Nithya J Gogtay ◽  
Urmila M Thatte
Keyword(s):  
Adverse Drug Events ◽  
The United States ◽  
Institutional Review Boards ◽  
Chi Square ◽  
Institutional Review ◽  
United States Food ◽  
Post Marketing ◽  
Chi Square Test ◽  
Us Fda ◽  
Review Boards

The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholders and further categorised as per predefined violation themes. The chi-square test was performed for trend analysis of WLs. A total of 62 WLs were issued to the three stakeholders. The maximum number of WLs were issued to the clinical investigators (36/62, 58.06%), followed by sponsors (19/62, 30.64%), and least to the IRBs (7/62, 11.29%). Among sponsors, lack of standard operating procedures for the monitoring, receipt, evaluation and reporting of post-marketing adverse drug events was the most common violation theme (8/19, 42.1%). Among clinical investigators, deviation from investigational plan was the most common violation theme (31/36, 86.11%.). For IRBs, inadequate documentation was the most common violation theme (6/7, 85.71%). We saw an overall reduction in the number of WLs issued to the stakeholders. Thus, we identified multiple areas on which each stakeholder should work for improvement.

scholarly journals Plant Protection and Quarantine: Helping U.S. Agriculture Thrive--Across the Country and Around the World, 2016 Annual Report

2017 ◽  
Author(s):  
Keyword(s):  
United States ◽  
Invasive Plant ◽  
Plant Protection ◽  
The United States ◽  
Agricultural Trade ◽  
Global Market ◽  
Plant Health ◽  
Market Place ◽  
Export Markets ◽  
The World

For Plant Protection and Quarantine (PPQ) and our partners, 2016 was a year of remarkable successes. Not only did we eradicate 10 fruit fly outbreaks, but we also achieved 4 years with zero detections of pink bollworm, moving us one step closer to eradicating this pest from all commercial cotton-growing areas of the continental United States. And when the U.S. corn industry faced the first-ever detection of bacterial leaf streak (Xanthomonas vasicular pv vasculorum), we devised a practical and scientific approach to manage the disease and protect valuable export markets. Our most significant domestic accomplishment this year, however, was achieving one of our agency’s top 10 goals: eliminating the European grapevine moth (EGVM) from the United States. On the world stage, PPQ helped U.S. agriculture thrive in the global market-place. We worked closely with our international trading partners to develop and promote science-based standards, helping to create a safe, fair, and predictable agricultural trade system that minimizes the spread of invasive plant pests and diseases. We reached critical plant health agreements and resolved plant health barriers to trade, which sustained and expanded U.S. export markets valued at more than $4 billion. And, we helped U.S. producers meet foreign market access requirements and certified the health of more than 650,000 exports, securing economic opportunities for U.S. products abroad. These successes underscore how PPQ is working every day to keep U.S. agriculture healthy and profitable.

scholarly journals EMERGENCY USE AUTHORIZATION: AT ZERO HOUR

2018 ◽  
Vol 3 (4) ◽  
pp. 18-23
Author(s):  
V. Balamuralidhara ◽  
Vaishnav A.M. ◽  
Bachu V. ◽  
Pramod Kumar T.M.
Keyword(s):  
Homeland Security ◽  
Ebola Virus ◽  
Hemorrhagic Fever ◽  
The United States ◽  
Vital Role ◽  
Test Device ◽  
Department Of Homeland Security ◽  
The Public ◽  
Life Threatening ◽  
Us Fda

The Emergency Use Authorisation (EUA) authority plays a vital role in US FDA. They provide the authority/permission to use the unregistered products/registered product with unregistered route to treat the life threatening damages to the patients in world in some emergency conditions. The aim of this work is to give an overview on EUA in life threatening conditions and there challenges in getting the permissions under regulations with example of E-bola virus. The e-bola is a virus. It is a hemorrhagic fever deadly disease caused by one of the E-bola viral strain, which is wide spread in West Africa. The -Secretary of the Department of homeland security (DHS), determined, pursuant to section 319F-2 of the Public Health Service Act, that the Ebola virus presents a material threat against the United States population sufficient to affect national security. Issuance of EUA by the FDA Commissioner requires several steps under section 564 of the FD&C Act. The FDA Commissioner, can only issue the EUA, if criteria for issuance under the statute are met. This study’s highlights the importance of the EUA in emergency when there is no medicine for disease/virus in the world. For example the FDA has issued a EUA to use the ReEBOV which is the Rapid Antigen Test device designed by Lusys lab co. Pvt. Ltd. for detecting the Zaire Ebola virus.

scholarly journals High global consumption of potentially inappropriate fixed dose combination antibiotics: Analysis of data from 75 countries

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0241899
Author(s):  
Barbara Bortone ◽  
Charlotte Jackson ◽  
Yingfen Hsia ◽  
Julia Bielicki ◽  
Nicola Magrini ◽  
...  
Keyword(s):  
The United States ◽  
Antibiotic Consumption ◽  
Essential Medicines ◽  
World Health ◽  
Fixed Dose ◽  
Middle Income ◽  
Us Fda ◽  
Analysis System ◽  
Health Organization ◽  
Data Analysis System

Antibiotic fixed dose combinations (FDCs) can have clinical advantages such as improving effectiveness and adherence to therapy. However, high use of potentially inappropriate FDCs has been reported, with implications for antimicrobial resistance (AMR) and toxicity. We used a pharmaceutical database, IQVIA-Multinational Integrated Data Analysis System (IQVIA-MIDAS®), to estimate sales of antibiotic FDCs from 75 countries in 2015. Antibiotic consumption was estimated using standard units (SU), defined by IQVIA as a single tablet, capsule, ampoule, vial or 5ml oral suspension. For each FDC antibiotic, the approval status was assessed by either registration with the United States Food and Drug Administration (US FDA) or inclusion on the World Health Organization (WHO) Essential Medicines List (EML). A total of 119 antibiotic FDCs were identified, contributing 16.7 x 109 SU, equalling 22% of total antibiotic consumption in 2015. The most sold antibiotic FDCs were amoxicillin-clavulanic acid followed by trimethoprim/sulfamethoxazole and ampicillin/cloxacillin. The category with the highest consumption volume was aminopenicillin/β-lactamase inhibitor +/- other agents. The majority of antibiotic FDCs (92%; 110/119) were not approved by the US FDA. Of these, the most sold were ampicillin/cloxacillin, cefixime/ofloxacin and metronidazole/spiramycin. More than 80% (98/119) of FDC antibiotics were not compatible with the 2017 WHO EML. The countries with the highest numbers of FDC antibiotics were India (80/119), China (25/119) and Vietnam (19/119). There is high consumption of FDC antibiotics globally, particularly in middle-income countries. The majority of FDC antibiotic were not approved by either US FDA or WHO EML. International initiatives such as clear guidance from the WHO EML on which FDCs are not appropriate may help to regulate the manufacturing and sales of these antibiotics.

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