scholarly journals Regulatory Prototype for Biological Products in the United States

2021 ◽  
pp. 60-72
Author(s):  
G. M. Pavithra ◽  
N. Venugopal
Keyword(s):  
Price Competition ◽  
Generic Drugs ◽  
The United States ◽  
Biological Application ◽  
Biological Products ◽  
License Application ◽  
The Us ◽  
High Degree ◽  
Degree Of Similarity ◽  
Improve Access

Biological products are used for the treatment of many disease, so the biological application submitted for the approval of products are also increasing. The progress of a biosimilarproduct is more difficult and expensive than a small molecule generic product. Biosimilars are not true generic drugs, but demonstrate a high degree of similarity to the reference biological product. In order to improve access to costly biological treatments, a biosimilar pathway in the US was established under the Biologics Price Competition and Innovation Act of 2009. The study highlighted the “Regulatory prospective for the registration of Biological products in US” and a brief description about the development, Manufacturing and approval process of biosimilar products. This article is also focused on the regulatory framework, Biological License Application, Purple book, and Pharmacovigilance of biological products.

Recent developments in US law: Remedies and damages for improper patent listings in the FDA's Orange Book

10.5912/jcb29 ◽  
1969 ◽  
Vol 9 (3) ◽  
Author(s):  
Daniel G Brown
Keyword(s):  
Price Competition ◽  
Generic Drugs ◽  
Pharmaceutical Product ◽  
Pharmaceutical Companies ◽  
White House ◽  
Drug Products ◽  
The Us ◽  
Recent Developments ◽  
The Usa ◽  
Orange Book

The Drug Price Competition and Patent Term Restoration Act (Publ. No. 98-417, 98 Stat. 1585 (1984)), commonly known as the Hatch–Waxman Act (the Act) provides the statutory framework by which most generic drugs are approved for marketing in the USA. Most provisions in the Act concern the standards and procedures the US Food and Drug Administration (FDA) must follow to approve generic drugs. A relatively small number of the provisions, however, create a framework for resolving patent disputes between the brand and generic pharmaceutical companies. These provisions have been the subject of much recent activity, in the US Courts, in Congress, in the FDA itself and in the White House. Much of the activity revolves around a publication by FDA entitled Approved Drug Products with Therapeutic Equivalence Evaluations, known colloquially as the Orange Book.Under present FDA practice, the mere listing of a patent in the Orange Book corresponding to a brand pharmaceutical product invokes a number of statutory provisions that confer valuable exclusivity rights on the brand company, and also possibly on one or more generic companies. This situation creates a strong incentive for patentees and brand pharmaceutical companies to list patents in the Orange Book. A number of recent court cases have addressed the remedies and damages available when the listing is found to be improper. Thus far, the most successful means to challenge or prevent improper listings has been through private and governmental enforcement of the antitrust laws.

What the patent dance of the Biosimilars Act means for biosimilars

2014 ◽  
Vol 20 (4) ◽  
Author(s):  
David A. Fazzolare ◽  
Joanna Brougher
Keyword(s):  
Price Competition ◽  
Market Entry ◽  
Patent Protection ◽  
Reference Product ◽  
Title Vii ◽  
President Obama ◽  
Biological Products ◽  
Related Information ◽  
The Us ◽  
Biologic Product

There are currently only two biosimilars on the market in the US in contrast to the 21 biosimilars have been approved in Europe since 2006. Part of the reason for the lack of biosimilars is that until recently, there has been no abbreviated pathway for a biosimilar to reach the market meaning that biosimilars had to undergo the long and costly process of obtaining approval just like an innovator biologic product. After years of negotiation, however, the Biologics Price Competition and Innovation Act (the “Biosimilars Act”) was signed into law on March 23, 2010, by President Obama as Title VII of the Patent Protection and Affordable Care Act. The Biosimilars Act established an abbreviated pathway by which the FDA could approve generic versions of previously licensed biological products. The Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called “Patent Dance” which describes the process by which the biosimilar applicant and the reference product sponsor (“RPS”) exchange patent-related information before the biosimilar can enter the market. In this article, we will explore what the Patent Dance is and what it means for biosimilars that are seeking market entry in the US. 

scholarly journals REVIEW ON SPONSOR / APPLICANT MEETINGS WITH FDA: HIGHLIGHTS OF NEW GUIDANCE OVER EXISTING

2018 ◽  
Vol 4 (2) ◽  
pp. 19-26
Author(s):  
Charmy Kothari ◽  
Kavina Shah
Keyword(s):  
Clinical Trials ◽  
Management Practices ◽  
Drug Application ◽  
Development Program ◽  
The United States ◽  
United States Department ◽  
Biological Products ◽  
New Drug ◽  
License Application ◽  
New Drug Application

The United States Department of Health and Human Services has a federal agency called the Food and Drug Administration (FDA or USFDA). A pre-planned assembling of two or more people who have been together for the purpose of getting a common goal via verbal interaction is called a formal meeting. During development stage of any drug or biological products pharmaceutical companies face trouble for both scientific and regulatory point of view, here role of formal meetings comes. Formal meetings between sponsor or applicant and FDA are usually related to development and review of drug and biological products. Center for Drug evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regulates the formal meetings. These meetings are applicable to Pre – Investigational New Drug Application, Pre – Biologics License Application, New Drug Application for drugs and biological products and not applicable to Abbreviated New Drug Applications (ANDA), application of medical devices and submission of biosimilar biological products. Meetings between FDA and sponsor or applicant are for resolution of dispute, clinical holds discussion, Assessment of protocols of clinical trial, during clinical trials, in between clinical trials – at the phase 1 ending or at the phase 2 ending, to discuss development program. The FDA has classified these formal meetings in different types based on the nature of the request, the information in the meeting request and each meeting type is handled through different procedures. The principles of Good Meeting Management Practices (GMMPs) must be maintained. There are specific requirements and procedures to request, prepare, schedule, conduct and document formal meetings. As the guidance documents for meetings are revised by FDA, Change in procedure and requirements takes place. Any pharmaceutical company need to be in line with new guidance requirements to avoid rejection. Formal meetings between sponsor or applicant and FDA save time, cost and will increase the probability of product approval.

scholarly journals Islets Transplantation at a Crossroads - Need for Urgent Regulatory Update in the United States: Perspective Presented During the Scientific Sessions 2021 at the American Diabetes Association Congress

2022 ◽  
Vol 12 ◽  
Author(s):  
Piotr Witkowski ◽  
Louis H. Philipson ◽  
John B. Buse ◽  
R. Paul Robertson ◽  
Rodolfo Alejandro ◽  
...  
Keyword(s):  
United States ◽  
Islet Transplantation ◽  
Organ Procurement ◽  
The United States ◽  
Regulatory Framework ◽  
Human Organs ◽  
Cell Tissue ◽  
License Application ◽  
The Us ◽  
Drug Manufacturing

Clinical islet allotransplantation has been successfully regulated as tissue/organ for transplantation in number of countries and is recognized as a safe and efficacious therapy for selected patients with type 1 diabetes mellitus. However, in the United States, the FDA considers pancreatic islets as a biologic drug, and islet transplantation has not yet shifted from the experimental to the clinical arena for last 20 years. In order to transplant islets, the FDA requires a valid Biological License Application (BLA) in place. The BLA process is costly and lengthy. However, despite the application of drug manufacturing technology and regulations, the final islet product sterility and potency cannot be confirmed, even when islets meet all the predetermined release criteria. Therefore, further regulation of islets as drugs is obsolete and will continue to hinder clinical application of islet transplantation in the US. The Organ Procurement and Transplantation Network together with the United Network for Organ Sharing have developed separately from the FDA and BLA regulatory framework for human organs under the Human Resources & Services Administration to assure safety and efficacy of transplantation. Based on similar biologic characteristics of islets and human organs, we propose inclusion of islets into the existing regulatory framework for organs for transplantation, along with continued FDA oversight for islet processing, as it is for other cell/tissue products exempt from BLA. This approach would reassure islet quality, efficacy and access for Americans with diabetes to this effective procedure.

Distinctive Characteristics of American Diplomacy

2011 ◽  
Vol 6 (3-4) ◽  
pp. 235-259 ◽  
Author(s):  
Geoffrey Wiseman
Keyword(s):  
United States ◽  
Foreign Policy ◽  
Soft Power ◽  
The United States ◽  
Department Of State ◽  
The Us ◽  
American Diplomacy ◽  
Domestic Influence ◽  
Multilateral Diplomacy ◽  
High Degree

My central claim is that the United States has conducted a distinctive form of ‘anti-diplomacy’, accepting in practice many diplomatic norms and practices while remaining reluctant to acknowledge the fact. To support this claim, this article argues that since its rise as a world power, the United States has participated in international society’s diplomatic culture in a distinctive way and that this distinctiveness stems from seven interconnected characteristics of American diplomacy: (1) America’s long-held distrust and negative view of diplomats and diplomacy, which has contributed to the historical neglect and sidelining of the US Department of State in the United States’ policy-making process; (2) a high degree of domestic influence over foreign policy and diplomacy; (3) a tendency to privilege hard power over soft power in foreign policy; (4) a preference for bilateral over multilateral diplomacy; (5) an ideological tradition of diplomatically isolating states that are considered adversarial and of refusing to engage them until they meet preconditions; (6) a tradition of appointing a relatively high proportion of political rather than career ambassadors; and (7) a demonstrably strong cultural disposition towards a direct, low-context negotiating style. A consequence of these distinguishing characteristics is that American diplomacy tends to be less effective than it might otherwise be, not only in advancing the United States’ own interests, but also in advancing wider international cooperation. A goal here is to provide a working framework with which to evaluate any US administration’s relationship to diplomacy as the country’s interests and identity evolve.

Adapting DRGs: The British, Canadian and Australian Experiences

1994 ◽  
Vol 24 (3) ◽  
pp. 87-93
Author(s):  
John Pilla ◽  
Don Hindle
Keyword(s):  
United States ◽  
Resource Allocation ◽  
The United States ◽  
High Degree ◽  
Degree Of Similarity

The DRG classification was developed in the United States, and has been widely used there for analytical and resource allocation purposes. Its utility has been recognised in other countries. Some have adopted US versions without change, and others have chosen to develop their own adaptations. This paper discusses the processes and outcomes of adaptation in Canada, Britain and Australia. An attempt is made to generalise the trends. It is concluded that there is a high degree of similarity of intent, although different solutions have been adopted in some cases. Where major differences remain, they are mostly a consequence of the lack of resources to pursue all opportunities for refinement at the same time. All three countries have correctly focused on involvement of their own clinician groups. However, they have tended to restrict their view to US experiences when looking overseas. It is argued that greater attention should be paid to sharing their ideas with countries with which they have a greater degree of similarity.

scholarly journals Perpetual decline or persistent dominance? Uncovering Anglo-America’s true structural power in global finance

2016 ◽  
Vol 43 (1) ◽  
pp. 3-28 ◽  
Author(s):  
Jan Fichtner
Keyword(s):  
New York ◽  
International Political Economy ◽  
The United States ◽  
Global Finance ◽  
Structural Power ◽  
The Us ◽  
English Speaking ◽  
The Stability ◽  
High Degree ◽  
Year 2000

AbstractThe prediction of America’s decline is a regularly recurring phenomenon; this also pertains to the pivotal field of global finance. This article argues that, first we have to consider the United States together with the other Anglophone countries. The English-speaking countries and territories – Anglo-America – have deep common political and socioeconomic roots, of which the unique global Five Eyes intelligence cooperation is merely one manifestation. In finance, New York and London (NY-LON) constitute the decision-making core of this transnational formation. Second, to analyse the highly complex phenomenon of structural power in the globalised international political economy we have to dig deeper to uncover truly meaningful data. Thus, this article evaluates data for nine central segments of global finance from around the year 2000 to 2014. Contrary to the assertions of many declinists, these data show that Anglo-America’s dominant structural power has been persistent during this period. Moreover, four novel visualisations show that the US-UK axis is the fulcrum of the international financial system. However, contemporary global finance is characterised by a high degree of latent fragility; significant imbalances, inequalities and contradictions persist and are even likely to grow, potentially undermining the legitimacy and the stability of the whole system.

scholarly journals Leveling the Playing Field: Industrial Policy and Export-Contingent Subsidies in India–Export Related Measures

2021 ◽  
pp. 1-17
Author(s):  
Swati Dhingra ◽  
Timothy Meyer
Keyword(s):  
United States ◽  
Trade Policy ◽  
Industrial Policy ◽  
Prescription Drugs ◽  
Generic Drugs ◽  
The United States ◽  
Playing Field ◽  
Enforcement Policy ◽  
The Us ◽  
Pharmaceutical Prices

Abstract In India–Export Related Measures, the United States challenged a range of Indian measures as prohibited export-contingent subsidies, and a WTO panel largely agreed. This article examines the factors at play in the United States’ decision to bring the challenge. At the level of policy, the United States case reflects India's graduation from the protections afforded developing nations’ export-contingent subsidies under the Agreement on Subsidies and Countervailing Measures. A closer examination, however, shows that India ramped up its export-contingent subsidies just as the SCM Agreement required it to wind those subsidies down. Moreover, the expanded Indian subsidies led to increased import competition with the politically influential metals and pharmaceutical sectors in the United States, which pushed the US challenge. We reflect on the larger implications of the challenge for the future of trade rules on industrial policy. In particular, we note that the United States pursued a trade enforcement policy that would have the effect of increasing pharmaceutical prices in the United States, by reducing subsidies for imported generic drugs, at a time when the Trump administration allegedly was trying to reduce the price of prescription drugs. This disconnect suggests the need for both greater transparency in trade policy and greater governmental coordination on the connection between trade policy and other policy priorities.

Biosimilars Regulation in the United States and FDA Approved Biosimilars from 2015-2018

2020 ◽  
Vol 7 (1) ◽  
pp. 12-29
Author(s):  
Vikram ◽  
Aakash Deep ◽  
Manita ◽  
Avtar C. Rana ◽  
Monu Yadav ◽  
...  
Keyword(s):  
Price Competition ◽  
Clinical Performance ◽  
Treatment Options ◽  
The United States ◽  
Living Cells ◽  
Human Beings ◽  
Biological Products ◽  
Technical Requirements ◽  
Manufacturing Techniques ◽  
High Level

Background: Biological products are the chemicals in the form of medicines that are prepared from the living cells through highly intricate manufacturing techniques that should be handled and managed under favorable conditions. The regulation of the biosimilar products consists of significant challenges, since they are part of the growing sector of the pharmaceutical industry and normally used by human beings. The regulatory framework and the technical requirements of the US biosimilars program involve a stepwise approach that relies heavily on analytical methods to demonstrate through a “totality of the evidence” that a proposed product is biosimilar to its reference product. By integrating analytical, pharmacological, and clinical data, each of which has limitations, a high level of confidence can be reached regarding clinical performance. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the health reform (Affordable Care Act). Objective: The current manuscript will provide the information regarding the regulation of Biosimilars products with the detail of biosimilar USER fees structure and the list of approved biosimilar by FDA from 2015- 2018. Conclusion: Research is continually developing more biological products that will help treat medical conditions or add some innovation to the existing treatment options. Biosimilars and reference products are generated in the living cells and require trained expertise as well as technology for biologics being usually highly effective compared to small molecule drugs. These are usually specific against the respective target, which generally produces lesser side effects and low toxicity. FDA’s regulatory authority for the approval of biologics is under PHS (Public Health Service Act) which are also suggested to regulate under the Federal Food, Drug and Cosmetics Act (FD&C). Biosimilars can help expand access to high-quality treatment options for doctors and patients, as well as reduce costs for the healthcare system.

Homoeopathy and the US primary care physician

1997 ◽  
Vol 86 (03) ◽  
pp. 131-138 ◽  
Author(s):  
Brian M. Berman ◽  
Susan M. Hartnoll ◽  
Betsy B. Singh ◽  
B. Krishna Singh
Keyword(s):  
Primary Care ◽  
Primary Care Physicians ◽  
The United States ◽  
Care Physician ◽  
Regional Study ◽  
Referral Rates ◽  
The Us ◽  
High Degree ◽  
Self Administered Questionnaire ◽  
And Training

AbstractThe purpose of this study was to assess US primary care physicians' levels of knowledge of and attitudes towards homoeopathy, as well as their practice and referral patterns, and desire for training in this field. Previous studies indicate low practice and referral rates, but high interest in training has been suggested by an earlier regional study. A structured, self-administered questionnaire was mailed to a hierarchical, stratified, random sample of physicians drawn from the American Medical Association membership of primary care specialists. Results of this study show a high degree of interest in training (49%) in homoeopathy despite current low practice (5.9%) and referral rates (13.8%). In addition, a total of one third of the physicians said they either would use or have used homoeopathy in their own practices. A shortfall exists between the knowledge and desire for knowledge about homoeopathy among primary care physicians and the availability or amount of information and training accessible in the United States.

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