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PubMed Journals Articles About "CAFC Affirms Apotex Biosimilars Infringe Amgen Patent" RSS

14:02 EST 14th December 2018 | BioPortfolio

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Showing "CAFC affirms Apotex biosimilars infringe Amgen patent" PubMed Articles 1–25 of 229

Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court's Recent Rulings do not Solve Fundamental Barriers to Competition.

Biologics and biosimilars are medicines made from living cells that treat common and serious diseases such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. They are highly targeted, efficacious, and represent an increasingly important part of physicians' armamentaria in the combat against these medical conditions. Yet they are extremely expensive, costing on average $10,000-$30,000 per year and exceed $500,000 for the most expensive biologics. The advent of biosimilar drugs, or hi...


The complexities of biosimilars and the regulatory approval process.

Created via the Biologics Price Competition and Innovation Act, the biosimilar class of drugs was conceived as an opportunity to introduce competition for commonly used biologics following loss of patent protection and market exclusivity, similar to the generic paradigm that has helped sustain access and innovation for more than 3 decades. The FDA approves a biosimilar after a manufacturer establishes that the product is highly similar to a previously approved originator biologic reference product without a...

Biosimilars: Expert consensus of the Latin American Society of Psoriasis (SOLAPSO) in Argentina.

With the appearance of biological treatments, therapeutics has changed in many rheumatological, dermatological and oncological diseases. Due to the high cost of these biological medicaments and the expiration of patents, the pharmacological industry develops biosimilars, drugs that are a version (copy) of the substance of the original biological medicine, with the aim of facilitating access to these treatments. These biosimilars are prepared according to the specific requirements of regulatory bodies in ter...


Patent term restoration for top-selling drugs in the USA.

Patents temporarily protect brand-name drugs from generic competition, but some of the 20-year patent term is used up before marketing approval. To compensate for patent life lost to clinical testing and regulatory review, current law provides patent term restoration (PTR) of up to 5 years. Examining 170 top-selling drugs approved between 2000 and 2012, we found that 49% (83 drugs) received a PTR extension (median extension: 2.75 years) yielding a median total exclusivity period of 13.75 years, compared wit...

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America.

Biological therapies have revolutionized the treatment of several cancers and systemic immune-mediated inflammatory conditions. Expiry of patents protecting a number of biologics has provided the opportunity to commercialize highly similar versions, known as biosimilars. Biosimilars are approved by regulatory agencies via an independent pathway that requires extensive head-to-head comparison with the originator product. Biosimilars have the potential to provide savings to healthcare systems and expand patie...

Practical Guidance on Biosimilars, With a Focus on Latin America: What Do Rheumatologists Need to Know?

Availability of biologic disease-modifying antirheumatic drugs (bDMARDs) has improved clinical outcomes in rheumatoid arthritis, but it also increased the cost of treatment. Biosimilars, the regulated copies of biologic products, have a potential to reduce health care costs and expand access to treatment. However, because of a complex development process, biosimilars can be considered only those noninnovator biologics with satisfactory supporting evidence (ranging from structural to clinical), as outlined i...

Opportunities and challenges in biosimilar uptake in oncology.

There are now 10 approved biosimilars in the United States, including 3 oncology drugs, and at least 16 others in late-stage development. The introduction of competition into the biologic space launches a new era in the treatment of cancer, possibly increasing access to the extremely costly biologics. The most important and influential stakeholders for biosimilar acceptance and usage are healthcare providers, such as pharmacists and physicians, as well as patients. Gaining their support requires extensive e...

The nocebo effect: a clinical challenge in the era of biosimilars.

The nocebo effect is defined as a negative effect of a pharmacological or non-pharmacological medical treatment that is induced by patients' expectations, and that is unrelated to the physiological action of the treatment. The nocebo effect is an important clinical challenge in the current era of biosimilars. Areas covered: This review aims to answer five key questions about the nocebo effect, namely to reveal its definition, pathophysiology, clinical relevance, contributing factors, and management. Expert ...

Do patents of academic funded researchers enjoy a longer life? A study of patent renewal decisions.

This paper assesses the extent to which patent renewal data is associated with government funding in a university context by focusing on the relationship between the funded patentees and renewal decisions of their patents. The aim of this paper is to show whether receiving funding from government contributes to high-value patents as measured by the patent renewal decisions made by their owners. Our observations of academic nanotechnology patents in Canada discovered a positive relationship between funded re...

How similar is biosimilar? A comparison of Infliximab therapeutics in regard to charge variant profile and antigen binding affinity.

Biosimilars are increasing in economic importance. Just how similar a biosimilar needs to be to gain market approval is currently still decided on a per case basis. We try to shed light on one often cited critical quality attribute of monoclonal antibodies, namely charge heterogeneity. Using high resolution electrophoretic and chromatographic methods, we are able to separate and quantify the charge variant content of infliximab originator and three biosimilars. Additionally we quantified and compared the an...

Correction to: To See or NOsee: The Debate on the Nocebo Effect and Optimizing the Use of Biosimilars.

The article "To See or NOsee: The Debate on the Nocebo Effect and Optimizing the Use of Biosimilars", written by Mourad F. Rezk and Burkhard Pieper was originally published electronically on the publisher's internet portal (currently SpringerLink) on June 5, 2018 without open access.

The Reporting Items for Patent Landscapes statement.

The reporting quality of patent landscapes is inadequate. The Reporting Items for Patent Landscapes (RIPL) checklist can improve reporting quality.

Use of Biosimilars in Paediatric Inflammatory Bowel Disease: An Updated Position Statement of the Paediatric IBD Porto Group of ESPGHAN.

Biologic therapies have changed the outcome of both adult and paediatric patients with Inflammatory Bowel Disease (IBD). In September 2013, the first biosimilar of infliximab was introduced into the pharmaceutical market. In 2015, a first position paper on the use of biosimilars in paediatric IBD was published by the ESPGHAN IBD Porto group. Since then, more data have accumulated for both adults and children demonstrating biosimilars are an effective and safe alternative to the originator. In this updated p...

Use and costs of originator and biosimilar erythropoiesis-stimulating agents in the treatment of chemotherapy-induced anemia: real-world evidence from an Italian hospital.

The aim of this retrospective study is to evaluate adherence, switch and costs a year after the start of treatment with different erythropoietin-stimulating agents. There were 277 patients, 200 were originators (72.20%) and 77 (27.80%) were biosimilars. Adherence to treatment for originators is 0.84 ± 0.22 versus 0.76 ± 0.27 for biosimilars (p = 0.3241). Medication adherence was calculated as ratio between received daily dose to prescribed daily dose. The optimum value is 1, values less than 1 indi...

Biosimilar Knowledge Among Oncology/Hematology Team Members in Colorado, USA: An Educational Initiative and Follow-Up Survey.

No data exist regarding oncology/hematology team members' knowledge of and views on biosimilars in Colorado, USA. Published research has suggested that health professionals may have a poor understanding of many issues related to biosimilars.

Anti-tumor necrosis factor biosimilars and intended copies in rheumatology: Perspective from the Asia Pacific region.

Although anti-tumor necrosis factor (TNF) agents have greatly improved the management of rheumatic diseases, their cost limits access to many patients throughout the world. As a result, patients and clinicians have turned to biosimilars to provide similar efficacy at a lower cost. Many of the regulatory guidelines in the Asia Pacific region are largely based on those of the European Medicines Agency and the World Health Organization; however, there are variations between countries. Additionally, in some cou...

Adaptive Seamless Design for Establishing Pharmacokinetic and Efficacy Equivalence in Developing Biosimilars.

Recently, numerous pharmaceutical sponsors have expressed a great deal of interest in the development of biosimilars, which requires clinical trials to demonstrate that the pharmacokinetic (PK) and clinical efficacy are equivalent. Pharmacodynamics (PD) may be used in evaluating efficacy if there are relevant PD markers available. However, in their absence, it is necessary to design the associated clinical trials to include efficacy measures as the primary endpoint.

The US Biosimilar Market: Stunted Growth and Possible Reforms.

In 2010, Congress created an abbreviated application pathway for biosimilars, versions of approved biologics made by different manufacturers. However, as of November 1, 2018, the Food and Drug Administration had approved only 13 biosimilars under this pathway, of which just 6 were available for patients to use. We review the history of US regulation of biologics and identify manufacturing, regulatory, and marketing issues that have limited biosimilar market entry and uptake, concluding with recommendations ...

Feasibility of patent and proprietary medicine vendor provision of injectable contraceptives: preliminary results from implementation science research in Oyo and Nasarawa, Nigeria.

Nigerian policymakers are debating task-shifting injectable contraceptive services to Patent and Proprietary Medicine Vendors (PPMVs).

Biosimilars.

Updated Meta-analysis on the Closure of Patent Foramen Ovale in Reduction of Stroke Rates: the DEFENSE-PFO Trial Does not Change the Scenario.

We aimed to analyze whether patent foramen ovale (PFO) closure reduces the risk of stroke, assessing also some safety outcomes after the publication of a new trial.

Reduced Stroke After Transcatheter Patent Foramen Ovale Closure: A Systematic Review and Meta-analysis.

Recent randomized control trials (RCTs) have suggested benefit with transcatheter patent foramen ovale (PFO) closure plus antiplatelet therapy over medical treatment alone for secondary stroke prevention.

Hemodynamically significant patent ductus arteriosus and the development of bronchopulmonary dysplasia.

Patent ductus arteriosus (PDA) is prevalent in premature newborns and has been linked to the development of bronchopulmonary dysplasia (BPD), a serious pulmonary complication of premature birth. Although a causal relationship has not been proven, the link is greatest among infants born at lower gestational age who are treated with mechanical ventilation in the presence of a large ductal shunt. Despite strong association in epidemiological studies, treatment of a patent ductus arteriosus has not been shown t...

Angiographic appearance of patent saphenous vein grafts more than 25 years after coronary artery bypass grafting.

Nine patients with ten angiographical patent saphenous vein grafts (SVG) more than 25 years after coronary artery bypass grafting (CABG) at Kawasaki Medical School Hospital between 1976 and 1992 were reviewed. Patent SVG disease was assessed using the FitzGibbon classification, and clinical characteristics which might affect the longevity of SVG were retrospectively evaluated. The mean duration between surgery and current coronary angiography was approximately 30 years (25-35 years). There were two perfe...

Clinical outcomes after more conservative management of patent ductus arteriosus in preterm infants.

Management of patent ductus arteriosus is still controversial. This study aimed to describe the impact of a more conservative approach on treatment rates and on main outcomes of prematurity, especially in preterm infants with


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