[The pleiotropic cytokine tumor necrosis factor (TNF)-α seems to be fundamentally involved in the pathogenesis of a variety of immune-mediated (partly autoimmune) chronic inflammatory disorders; therefore, its blockade has allowed a remarkable advance in treatment strategies. Safety and tolerability profile of TNF-antagonists is generally favorable, their overall risk/benefit ratio is definitely positive. Possible adverse consequences related to TNF-α blocking monoclonal antibodies and soluble receptors can be classified as class-specific side effects that are related to their mode of action, and individual, molecule-specific effects. Immunogenic potential of immunoglobulins (Ig) eliciting an anti-(Ig-) antibody immune response may reduce or eliminate their therapeutic benefit, increase the risk of resistance or intolerance to biologic agents, and also lead to other adverse clinical effects. The immunogenicity profile of TNFantagonists is mainly related to their hetero- (xeno-), allo- (iso-)genic or idiotypic antigen character. By means of generating fully human monoclonal antibodies, more tolerable drugs could be introduced into clinical practice.]

[The original patent drugs appear immediately on expiry of all rights in generic and biosimilar drugs in the pharmaceutical market, favorable supply option which helps in the rational management of medicines, mainly for generic drugs cheaper to allow more patient care. Of course, this is a well-organized legal and regulatory framework, thoughtful strategy can be successful in every respect. In another non-identical molecular structure biosimilar drugs in different immunogenicity of knowledge and risk is not defined in clinical practice and therefore the risk is still underestimated and not well regulated in the world, and increasing the number reported is the antibody formation case of a biosimilar erythropioetin also. The immunogenicity of original biological and of biosimilar drugs in identifying, defining a prominent role in the post-marketing surveillance, pharmacovigilance, and the special methods of control of immunogenicity. The original and the biosimilar medicines interchangeability, marketability of the assets relating to the regulations are not uniform in Europe or the European registration scheme is an important new biosimilar medicinal products, is that the medicinal product, the documentation is not expected to be accompanied by a risk management plan, as well as action to ensure the safety (pharmacovigilance) as part of the collection and reporting of adverse reactions to the official. It is important that the professional management of renal anemia guidelines - the practice of nephrology erythropoietin therapy - clearly define the biological medicines (originator and biosimilar erythropoietin) application requirements and suggestions. Consequently, this summary wants to draw attention to the therapeutic potential of biosimilar drugs, generic drugs to distinguish between explicit and the potential risks and the need to reduce the risks of professional and health policy decisions.]

[In this review, we follow the consecutive steps of the internationally accepted therapeutic strategy of rheumatoid arthritis (RA). We summarise in brief the current European recommendations, and provide some advice on methotrexate (MTX) therapy. The initiation, maintenance and, if needed, switch of biological therapy is also discussed. Having reached remission or low disease activity (LDA), tapering or discontinuation of biologics may be considered. Finally, we review the possibilities and the most important biomarkers of personalised treatment.]