Therapeutische Umschau. Revue thérapeutique
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The introduction of monoclonal antibodies has been a milestone in the treatment of hematologic neoplasms. The CD20 antibody rituximab has been a trailblazer and represents meanwhile a fixed combination partner of different first- and second-line chemotherapies in CD20-positive B-cell-non-Hodgkin's lymphoma (NHL). Rituximab maintenance is established in follicular lymphoma. ⋯ Rituximab was followed by the CD52 antibody alemtuzumab and recently by the CD20 antibody ofatumumab for the therapy of CLL and the radioimmunconjugate ibritumomab-tiuxetan indicated for the treatment of refractory or relapsed CD20-positive follicular lymphoma or as consolidation after induction chemotherapy. In the near future, approval of several new antibodies is expected. For the treatment of refractory or relapsed Hodgkin's lymphoma and relapsed systemic anaplastic large cell lymphoma, the CD30 antibody brentuximab vedotin has been shown to be a highly active new treatment option.
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This review describes some natural proteins, which can be employed, either as factor concentrates derived from human plasma or as recombinant drug, to modulate the coagulation system. I will address some biochemical characteristics and the physiological role of von Willebrand factor, the coagulation factors of the extrinsic and intrinsic pathways, and the physiological anticoagulant protein C. ⋯ In particular, I will address some treatment topics of general medical interest, such as the treatment of massive bleeding, the correction of the coagulopathy induced by vitamin K-antagonists in patients with cerebral haemorrhage, and of the coagulopathy of meningococcemia. Finally, I will describe some properties and practical clinical applications of the recombinant anticoagulans lepirudin and bivalirudin, which are derived from hirudin, the natural anticoagulant of the medical leech.
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Biosimilars are biological medicinal products referring to an existing biological originator product and submitted to regulatory authorities formarketing authorization by an independent applicant after the patent has expired. The European Medicines Agency (EMA) has issued overarching and specific guidelines that should be fulfilled in order to receive approval as biosimilar. ⋯ Points to consider when switching from the innovator product to a biosimilar, or from one biosimilar to another, are reported. INN-naming, labelling, pharmacovigilance issues, interchangeability, and substitution of biosimilars are still a matter of discussion.