No abstract

Leading scientists and influential professional societies have been warning of the dangers of emerging infections and the threat of a global pandemic for years, but nobody imagined that the new decade would open with the most significant global public health challenge of our lives. The emergence and subsequent spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has surpassed many of our expectations as the evolving global public health and economic crisis continues to change our personal and professional lives. Although the disease started in China in December 2019, as of 27 March 2020 it had rapidly affected more than half a million people in 176 countries, and these numbers are bound to increase further. A significant proportion of adult patients require hospitalization and may develop life-threatening complications whereas children do not usually develop serious disease but they can transmit the virus. This suggests that age and host-specific environmental factors seem to affect the containment and clearance of the virus, as well as inflammation-related tissue and organ damage...

No abstract

In the last 10 years, the growing approval and marketing of biological agents has significantly ameliorated the outcomes of rheumatoid arthritis and spondyloarthritis patients suffering from active and refractory disease despite conventional treatments. As patent protection of many biopharmaceuticals will expire in the next years, biosimilars could be proximally introduced. Such agents could be marked only when they will be proven, through in vitro and in vivo studies, to be similar enough to the original comparator in term of quality, efficacy and safety. As biosimilars are less expensive than corresponding originators, a wider use of these drugs may substantially cut off the expenditure of biopharmaceuticals. Nevertheless, ongoing debate exists in scientific community: the intrinsic complex and large structure of biologic molecules besides the natural variability in the manufacturing processes might lead to a slightly different product respect to the original one, so that relevant implications for efficacy and safety concerns might arise, especially in the long-term period. Immunogenicity and extended indications of biosimilars represent further matter of discussion, too. Thus, before their approval and marketing, specific guidelines and steps imposed by national and/or international regulatory agencies should be followed along with the respect of scientific societies position in each specific contest.