Results 21 to 30 of about 40,241 (253)
Pharmacovigilance of Biosimilars [PDF]
, 2013 In lieu of an abstract, here is the article\u27s first paragraph: Biotech industry forms the backbone of the current pharmaceutical products. Seven out of top ten anticipated drugs of the industry in 2014 will be biologics [1].
Chablani, Lipika
core +2 more sources
Frontiers in Medicine, 2022 Background Beyond evaluation and approval, European and national regulators have a key role in providing reliable information on biosimilars and the science underpinning their development, approval, and use.
L. Barbier +5 more
semanticscholar +1 more source
An Introduction to Biosimilars for the Treatment of Retinal Diseases: A Narrative Review
Ophthalmology and Therapy, 2022 Biological therapies have revolutionized the treatment of disease across a number of therapeutic areas including retinal diseases. However, on occasion, such treatments may be relatively more expensive compared to small molecule therapies.
S. Hariprasad +5 more
semanticscholar +1 more source
Clinical pharmacology and therapy, 2020 To date, no consensus exists among stakeholders about switching patients between reference biological products (RPs) and biosimilars, which may have been curbing the implementation of biosimilars in clinical practice. This study synthesizes the available
L. Barbier +5 more
semanticscholar +1 more source
Biological patent thickets and delayed access to biosimilars, an American problem
Journal of Law and the Biosciences, 2022 Our study seeks to determine whether patent thickets covering biologic drugs are responsible for delayed biosimilar market entry. We compare patent assertions against the same biosimilar drugs across three countries.
Rachel Goode, Bernard H. Chao
semanticscholar +1 more source
The Coming of Age of Biosimilars: A Personal Perspective
Biologics, 2022 Biosimilars have come of age over the past 17 years, with 84 approvals in the EU and 35 in the US, representing almost 90% of the world market. While the acceptance of biosimilars in the US is catching up with that in the EU, the cost benefits remain ...
Sarfaraz K Niazi
semanticscholar +1 more source
Tumor necrosis factor inhibitors in psoriatic arthritis. [PDF]
, 2017 INTRODUCTION: Psoriatic arthritis (PsA) is a chronic inflammatory disease that can result in significant disability. With the emergence of tumor necrosis factor inhibitors (TNFi), therapeutic outcomes in PsA have improved substantially.
Kraft, Walter K. +2 more
core +2 more sources
JAMA Oncology, 2022 Importance Biologics account for almost half of US drug spending but may be subject to competitive pricing pressures by US Food and Drug Administration-approved biosimilars.
D. Bloomfield +3 more
semanticscholar +1 more source
Forced Degradation Testing as Complementary Tool for Biosimilarity Assessment [PDF]
, 2019 Oxidation of monoclonal antibodies (mAbs) can impact their efficacy and may therefore represent critical quality attributes (CQA) that require evaluation.
Dyck, Yan Felix Karl +6 more
core +1 more source
Oncology biosimilars: New developments and future directions
Cancer Reports, 2022 Biologicals have become an integral part of cancer treatment both as therapeutic agents and as supportive care agents. It is important to know that biologics are large, complex molecular entities requiring extensive immunogenicity testing and ...
Rinda Devi Bachu +7 more
semanticscholar +1 more source