B Acad Nat Med Paris
-
B Acad Nat Med Paris · Oct 2020
Review[Biosimilar medicines: Regulatory issues and medico-economic impacts].
The concept of biosimilar medicine was launched by 2001 and 2004 European Directives. First European marketing authorizations were delivered in 2006. They are "copies" of biologically manufactured medicines, mostly proteins. ⋯ Introduction of biosimilar medicines of monoclonal antibodies has represented a remarkable event in the domain of rheumatology, gastroenterology and dermatology with infliximab, etanercept and adalimumab biosimilars and in cancerology domains with rituximab, trastuzumab and bevacizumab biosimilars. Biosimilar medicines availability reduces the risk of drug supply rupture of princeps but their main impact is the economic one allowing cost reduction of costly princeps biological medicines. With the acquired clinical experience, the initial fears concerning switch form princeps to a biosimilar for a given patient has progressively disappeared.
-
B Acad Nat Med Paris · Oct 2020
Review[Update on treatments and innovations in systemic auto-immune diseases].
Many new drugs, sometimes promising, are now available to treat systemic auto-immune diseases. Treatment strategies and objectives are different according to each auto-immune disease. Major advances have been obtained in vasculitides treatments. ⋯ Unfortunately, new drugs remain rare on the market and no major advances have been obtained. In systemic sclerosis, symptomatic treatments improved outcomes but effective drugs targeting all disease manifestations are missing. Autologous hematopoietic stem cell transplantation could be one of the future innovative treatment of systemic sclerosis despite the occurrence of adverse events.