SP-017 PRODUCTS SITUATION OF THE BIOSIMILARS IN TURKEY AND IN THE WORLD

Abstract

SP-017 – Table 1. Registered biosimiliars in Turkey (2009–2013) Product name Active substance Production site Reg. year, licensee LEUCOSTIM FILGRASTIM SOUTH KOREA (DONG-A) 2009, DEMMEDIKAL VE ECZA DEPOSU SAN VE TIC. LTD. STI. EPOBEL EPOETIN ZETA GERMANY (STADA) 2009, NOBEL ILAC PAZARLAMA VE SAN. LTD. STI. EPORON EPOETIN ALFA SOUTH KOREA (DONG-A) 2011, DEMMEDIKAL VE ECZA DEPOSU SAN VE TIC. LTD. STI. OMNITROPE SOMATROPIN AUSTRIA (SANDOZ) 2011, SANDOZ ILAC SAN. VE TIC. A.S. OKSAPAR ENOXAPARIN SODIUM TURKEY 2012, KOCAK FARMA ILAC VE KIMYA SAN. A.S. CLOTINAB ABCIXIMAB SOUTH KOREA (DONG-A) 2012, DEMMEDIKAL VE ECZA DEPOSU SAN VE TIC. LTD. STI. EPOPLUS EPOETIN ALFA CUBA 2013 HASBIOTECH ILAC SAN. VE TIC. A.S. ENOX ENOXAPARIN SODIUM TURKEY 2013, ATABAY KIMYA SAN. VE TIC. A.S. DROPOETIN EPOETIN ALFA TURKEY 2013, DROGSAN ILACLARI SAN. VE TIC. A.S. within 5 years of diagnosis. Thrombosis and CKD are leading causes of death in PNH: 40–67% of death are due to venous and arterial thrombosis, 64% of patients have CKD, which causes mortality in 8–18% of those patients. aHUS is a severe life-threatening disorder of uncontrolled complement activation resulting in thrombotic microangiopathy (TMA) in children and adults. TMA has a devastating impact on kidneys and other vital organs, 60% pf patients require dialysis, undergo kidney transplant or die within 1 year of diagnosis. The humanized monoclonal antibody eculizumab inhibits the terminal complement cascade by binding to human complement protein C5, inhibiting the formation of proinflammatory, prothrombotic C5a and C5b, with subsequent inhibition of assembly of the membrane attack complex. Multinational clinical studies in patients with PNH and aHUS demonstrated that eculisumab induces a rapid and clinically significant reduction in intravascular hemolysis and thrombotic events in PNH patients and TMA control and improvement of renal function in patients with aHUS. The data from Russian PNH and aHUS Registry present the demographic and clinical characteristics, incidence of complications and experience of patient treatment. Russian cohort in PNH Registry counts app 500 pts, aHUS app 40 pts. Recent achievements in diagnostic and treatment of PNH and aHUS made us responsible for the National guidelines development. There are several disease models described in the PNH guidelines where Russian experts recommend to use pathogenetic treatment. aHUS diagnostic and treatment experience also resulted in the Experts position paper and requires further consolidated efforts to prepare useful document for the medical community. SP-020 DIAGNOSIS, CLINICAL MANAGEMENT AND STEWARDSHIP FOR INVASIVE FUNGAL DISEASE IN HAEMATO-ONCOLOGY S.G. Agrawal. Department of Haemato-Oncology, Stem Cell Laboratory and Immunophenotyping Sections, Barts Health NHS Trust, London; Pathology Group, Blizard Institute, Queen Mary University of London, UK Antimicrobial stewardship has become a headline priority for governments and for international bodies, such as WHO. Antifungal stewardship is a highly specialized subset of this approach. I will discuss stewardship in the context of Haemato-Oncology as a further tool to ensure optimal patient management and resource utilization, over and beyond the development of care pathways for invasive fungal disease (IFD). A successful pathway requires “ownership” of the pathway by the clinical team looking after the patient, radiology, microbiology, infectious disease and respiratory physicians. . . My presentation will focus on the current debate on management strategies for IFD in Haemato-Oncology and the changes in our management algorithms over the last 12 years at St Bartholomew’s Hospital, London. I will present our updated diagnostic strategy, which uses three tests directed at Aspergillus detection – PCR, galactomannan and the LFD assay. The introduction of this triple testing strategy – “TRIADx” – will support the antifungal stewardship team, which will work closely with the Haemato-Oncology physicians and guide all aspects of IFD management.