Current Pharmaceutical Design - Volume 23, Issue 44, 2017

Background: Biological products are subject to constant reappraisal by regulatory agencies and pharmaceutical companies once they have entered the market, since every improvement in their manufacturing process has the potential to alter the basic properties of these molecules. Methods: Narrative review focusing on scientific literature as well as legal documents from regulatory agencies. Results: Evaluating the impact of Read More

The expiry of the patent of several leading biological medicinal products has led to a surge in the development of ‘biosimilar’ products. However, in contrast to generic small-molecule medicines, biosimilars are not identical to their reference medicinal products. Full comparability in quality as well as in preclinical and clinical issues is required to register a biosimilar. The potential to induce antidrug antibodies after treatment with bi Read More

Background: Biologic drugs have revolutionised the management of many inflammatory conditions. Patent expirations have stimulated development of highly similar but non-identical molecules, the biosimilars. Extrapolation of indications is a key concept in the development of biosimilars. However, this has been met with concerns around mechanisms of action, equivalence in efficacy and immunogenicity, whic Read More

Background: Infliximab biosimilars are the first biosimilars of monoclonal antibodies approved by the main regulatory agencies. Up to the present day, two infliximab biosimilars have been approved: CT-P13 (Celltrion), and SB2 (Biogen), but other companies have been developing candidate infliximab biosimilars that are on clinical trials: PF 06438179 (Pfizer), the ABP710 (bioCentury/Amgen) the BCD055 (JSC Biocad Russica) a Read More

Background: biosimilars are similar versions of existing innovator biologic agents but with distinct manufacturing processes. They were approved in inflammatory bowel disease (IBD) by extrapolation of indication from rheumatic diseases. As regulatory requirements for biosimilar approval focus on pre-clinical evidence of similarity rather than clinical data on efficacy, safety and immunogenicity, it is critical to review clinical eviden Read More

Background: Biological drugs represent highly effective but costly treatments for chronic immunemediated inflammatory diseases posing substantial burden on health care budgets. Introduction of biosimilars since 2013 has brought forward the potential of market competition, and as a societal benefit, the hope of increased access at a lower cost. Objective: We aim to provide a descriptive review on economic aspects a Read More

Background: Biosimilars have the potential to create competition, lower costs, and increase patient access to biological medications. However, biological medications are sensitive to their manufacturing processes and difficult to precisely characterize, leading to questions about substitution and interchangeability among products. Methods: This article reviews the role of biosimilars in patient access to therapeutic antibodies. Read More

A review of applications of the Immobilized Artificial Membrane (IAM) chromatography in drug discovery is given. IAM chromatography is presented as a tool to predict the interactions of solutes with biomembranes, blood-brain barrier permeability, volume of distribution, oral and skin absorption of drugs and compared to other in vitro techniques used to study drug bioavailability (caco-2 cells, liposome partition). Unbound phosph Read More

Hypertension can be referred to as modern scourge in 2017 and although, it seems that an improvement has been done during the passage of time, the full treatment still remains an unmet achievement for clinicians. Hypertension incidence in Mediterranean countries, especially Greece and Turkey, seems to be increasing irrespective of the expected protective effect of Mediterranean diet. The changed lifestyle and dieta Read More

Background: Platelet endothelial aggregation receptor 1 (PEAR1) may affect platelet-platelet contact and aggregation. The aim of this study was to assess the association between PEAR1 polymorphisms and risks of platelet aggregation. Methods: We searched the PubMed, EmBase, and Cochrane Library electronic databases for articles published through November 30th. 2016. Meta-analysis was performed to examine th Read More

Epigenetic modifications regulate chromatin folding and function. Epigenetic mechanisms regulate transcription mediating effects of various stimuli on gene expression. These mechanisms are involved in transcriptional control in various physiological and pathological conditions including neuropsychiatric disorders and behavioral abnormalities such as depression. In rodents, exposure to chronic social stress was shown to i Read More

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most commonly used medications in inflammatory illnesses. However, the gastrointestinal bleeding and toxicity associated with NSAIDs long term use prompted the quest towards investigations for new anti-inflammatory agents. Natural and natural-derived molecules proved its anti-inflammatory efficacy in vitro as well as in vivo. Given this background, the scope of this r Read More