نتایج جستجو برای: biosimilar

تعداد نتایج: 1870  

Journal: :Journal of managed care & specialty pharmacy 2015
Mike Baldziki Jeff Brown Hungching Chan T Craig Cheetham Thomas Conn Gregory W Daniel Mark Hendrickson Lutz Hilbrich Ayanna Johnson Steven B Miller Tom Moore Brenda Motheral Sarah A Priddy Marsha A Raebel Gurvaneet Randhawa Penny Surratt Cheryl Walraven T Jeff White Kevin Bruns Mary Jo Carden Charlie Dragovich Bernadette Eichelberger Edith Rosato Todd Sega

BACKGROUND The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will li...

2016
Kathryn Chapman Akosua Adjei Paul Baldrick Antonio da Silva Karen De Smet Richard DiCicco Seung Suh Hong David Jones Michael W. Leach James McBlane Ian Ragan Praveen Reddy Donald I. H. Stewart Amanda Suitters Jennifer Sims

Biosimilars are biological medicinal products that contain a version of the active substance of an already authorised original biological medicinal product (the innovator or reference product). The first approved biosimilar medicines were small proteins, and more recently biosimilar versions of innovator monoclonal antibody (mAb) drugs have entered development as patents on these more complex p...

2013
Carsten Lindemann Silke Mayer Miriam Engel Petra Schroeder

Background For the development of biosimilar monoclonal antibodies (mAb) or related substances containing the IgG Fc part it is mandatory to fully compare immunological properties between originator and biosimilar in a “comparability exercise” [1]. The most complex Fc associated function to mediate antibody dependent cellular cytotoxicity (ADCC) needs to be characterized using the active substa...

2017
Joseph Markenson Daniel F Alvarez Ira Jacobs Carol Kirchhoff

To make informed decisions about the safety, efficacy, and clinical utility of a biosimilar, health care providers should understand the types and be able to analyze data generated from a biosimilar development program. This article reviews the biosimilar guidelines, the biosimilar development process to provide education and context about biosimilarity, and uses examples from infliximab biosim...

2013
Carsten Lindemann Silke Mayer Miriam Engel Petra Schroeder

Background For the development of biosimilar monoclonal antibodies or related substances containing the IgG Fc part it is mandatory to fully compare immunological properties between originator and biosimilar in a “comparability exercise” [1]. The important Fc associated functions to mediate antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) need to be ch...

Journal: :International journal of clinical pharmacology and therapeutics 2017
Andrea Messori Sabrina Trippoli Claudio Marinai

Since biosimilars generally have undergone less clinical research than originators, their place in therapy can be strengthened by increasing the amount of clinical evidence supporting their approval. This report describes an approach in which a "total evidence" network meta-analysis is performed that compares the biosimilar not only with the originator but also with the previous standard of car...

2016
Simran J. Kaur Darryl Sampey Lester W. Schultheis Leonard P. Freedman William E. Bentley

Last month, Part 1 of this discussion brief ly described the regulatory landscape for developing biosimilar therapeutic monoclonal antibodies (TMAbs). We identified certain specific structural components of TMAb drug substances that warrant particular attention because alterations to them are likely to affect therapeutic safety and effectiveness. Now we conclude by considering whether studies o...

Journal: :Acta dermatovenerologica Croatica : ADC 2017
Rodica Olteanu Alexandra Zota Magda Constantin

Biosimilars represent a new trend in the treatment of many immune-mediated inflammatory diseases. Regulatory requirements for approval of biosimilars are different from those of originators and rely mostly on the evidence generated from bioequivalence studies and in particular from RCTs. Our goal in this review was to search for relevant studies from randomized controlled trials on the biosimil...

Journal: :Journal of diabetes science and technology 2014
Alasdair R Wilkins Manu V Venkat Adam S Brown Jessica P Dong Nina A Ran James S Hirsch Kelly L Close

Given that a new wave of biosimilar insulins will likely enter the market in coming years, it is important to understand patient perspectives on these biosimilars. A survey (N = 3214) conducted by the market research company dQ&A, which maintains a 10 000-patient panel of people with type 1 or type 2 diabetes in roughly equal measure, investigated these perspectives. The survey asked whether pa...

2015
Halvard Bonig Petra S Becker Arnd Schwebig Matthew Turner

Biosimilars are approved biologics with comparable quality, safety, and efficacy to a reference product. Unlike generics, which are chemically manufactured copies of small-molecule drugs with relatively simple chemical structures, the biosimilar designation is applied to drugs that are produced by living organisms, implying much more difficult to control manufacturing and purification procedure...

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